1. WIXOM, Mich., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that Triferic AVNU (ferric pyrophosphate citrate injection), the intravenous (IV) formulation of Triferic, is now available to patients in the United States. Triferic AVNU was approved by the U.S. Food and Drug Administration (FDA) in March 2020 and is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

    "The commercial availability of Triferic AVNU is good news for patients with chronic kidney…

    WIXOM, Mich., Feb. 09, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that Triferic AVNU (ferric pyrophosphate citrate injection), the intravenous (IV) formulation of Triferic, is now available to patients in the United States. Triferic AVNU was approved by the U.S. Food and Drug Administration (FDA) in March 2020 and is indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

    "The commercial availability of Triferic AVNU is good news for patients with chronic kidney disease on hemodialysis and their healthcare providers. This IV formulation is an important line extension of Triferic Dialysate," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "With Triferic AVNU, more patients will have access to the benefits of Triferic as providers will have added flexibility to administer the IV formulation to their patients who may benefit from physiologic iron maintenance therapy to manage their anemia."

    Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin. While Triferic Dialysate is designed to be administered via liquid bicarbonate, Triferic AVNU is designed for direct IV infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians. Triferic AVNU can be administered regardless of a dialysis center's mode of bicarbonate delivery. Many dialysis centers in international markets and an increasing number of dialysis centers in the U.S. have converted to the use of dry bicarbonate cartridges or bags and online dialysate generation, which is not compatible with Triferic Dialysate.

    Triferic AVNU is available for commercial purchase directly through Rockwell Medical and our exclusive distributor, Metro Medical™, a Cardinal Health company, to expand market availability and ease of ordering. Metro Medical has a long history as a leading distributor of pharmaceuticals and medical supplies to nephrology practices and clinic-based dialysis centers in the U.S., the focus market for Triferic ANVU.

    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 replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating functional iron deficiency in end-stage kidney disease patients.

    The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.

    IMPORTANT SAFETY INFORMATION FOR TRIFERIC AND TRIFERIC AVNU

    INDICATION

    TRIFERIC and TRIFERIC AVNU are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

    Limitations of Use

    TRIFERIC and TRIFERIC AVNU are not intended for use in patients receiving peritoneal dialysis. TRIFERIC and TRIFERIC AVNU have not been studied in patients receiving home hemodialysis.

    Warnings and Precautions

    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.

    Adverse Reactions

    Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

    To report an Adverse Events (AE) or Product Quality Control (PQC) please call the Medical Information Department at (855) 333-4315 or e-mail at .

    For full Safety and Prescribing Information please visit www.Triferic.com and www.Trifericavnu.com.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for 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.

    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, the impact of COVID-19 on Rockwell Medical's business and operations, the commercialization of Triferic Dialysate, the launch and commercialization of Triferic AVNU, the commercialization and applicability of Triferic AVNU in international markets, and the development plans and timing for Rockwell Medical's FPC pipeline candidates. 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 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, the commercial launch of Triferic AVNU, and the ability to secure international partners; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate and Triferic AVNU; the success and timing of our commercial launch of Triferic AVNU in the United States; the ability to manufacture Triferic Dialysate and Triferic AVNU in a cost effective manner; the reimbursement of Triferic Dialysate and Triferic AVNU in international markets; the success and timing of the development of our FPC pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; 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 September 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/0f76fe57-5fe6-4f9e-b2ad-b78737f253a9

     



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  2. WIXOM, Mich., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management, today announced that its partner in South Korea, Jeil Pharmaceutical Co., Ltd., filed New Drug Applications (NDA) with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic AVNU and Triferic Dialysate for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

    "The NDA submissions by our partner, Jeil Pharmaceutical, is an important milestone for Rockwell Medical as well as for the more than 82,000 patients in South Korea undergoing hemodialysis…

    WIXOM, Mich., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management, today announced that its partner in South Korea, Jeil Pharmaceutical Co., Ltd., filed New Drug Applications (NDA) with the Ministry of Food and Drug Safety (MFDS) of the Republic of Korea for Triferic AVNU and Triferic Dialysate for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

    "The NDA submissions by our partner, Jeil Pharmaceutical, is an important milestone for Rockwell Medical as well as for the more than 82,000 patients in South Korea undergoing hemodialysis," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "We expect Triferic to become an important new treatment option for dialysis clinics and the patients they serve, if approved by the MFDS. We look forward to continuing our productive relationship with Jeil as they advance both Triferic presentations through the regulatory process."

    In September 2020, Rockwell Medical entered into an exclusive license agreement with Jeil for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea. In consideration for the license, Rockwell Medical received an upfront fee and will be eligible for milestone payments and royalties on net sales.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for 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 replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating Functional Iron Deficiency in end-stage kidney disease patients.

    The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.

    Important Safety Information

    TRIFERIC and TRIFERIC AVNU are indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).

    TRIFERIC is not intended for use in patients receiving peritoneal dialysis. TRIFERIC has not been studied in patients receiving home hemodialysis.

    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.

    Most common adverse reactions (incidence ≥3% and at least 1% greater than placebo) in controlled clinical studies include: headache, peripheral edema, asthenia, AV fistula thrombosis, urinary tract infection, AV fistula site hemorrhage, pyrexia, fatigue, procedural hypotension, muscle spasms, pain in extremity, back pain, and dyspnea.

    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, the receipt milestone payments and royalties by Rockwell Medical, the timing of product sales in South Korea, the receipt of regulatory approvals in South Korea and the potential market opportunity for Triferic in South Korea. 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 impact of the COVID-19 pandemic (including, applicable federal, state or local orders) on business and operating results; receipt of regulatory approval for Triferic in South Korea; our ability to successfully launch both formulations of Triferic which will impact Rockwell's ability to achieve milestones and receive royalty payments; the ability to manufacturer the product in accordance with South Korean regulations, anticipated market opportunity in South Korea; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended June 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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  3. WIXOM, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country.

    "The initiation of this pivotal trial is an important milestone in our strategic plan to expand global access to Triferic," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer…

    WIXOM, Mich., Jan. 13, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that its partner in China, Wanbang Biopharmaceuticals, a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., enrolled the first patient in a pivotal Phase 3 trial for Triferic Dialysate to support a new drug application for regulatory approval in that country.

    "The initiation of this pivotal trial is an important milestone in our strategic plan to expand global access to Triferic," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "In China, hemodialysis has continued to increase at a rapid rate in recent years, with more than 600,000 patients receiving hemodialysis every year, making it the largest single market in the world. Wanbang Biopharmaceuticals is a leading pharmaceutical company and an outstanding partner to bring our therapy to patients in China."

    "We believe Triferic has the potential to greatly improve the lives of patients on dialysis in China, and we are pleased to have dosed the first patient in our pivotal trial," said Mr. Shibin Wu, Chief Executive Officer of Wanbang Biopharmaceuticals. "Wanbang Biopharmaceuticals is committed to addressing the needs of CKD patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital dialysis settings. We value our partnership with Rockwell Medical, and our collaboration enhances Wanbang Biopharmaceuticals' pipeline of innovative product candidates."

    The Phase 3 trial [RMFPC-13] is a prospective, randomized, single-blind (patient), parallel two-arm, placebo-controlled, multicenter, study of the efficacy and safety of Triferic® administered via hemodialysate in maintaining iron delivery and hemoglobin concentration in anemic adult patients with chronic kidney disease requiring hemodialysis. The objective of the study is to confirm the efficacy and safety of Triferic administered at each hemodialysis treatment via hemodialysate in maintaining iron delivery for erythropoiesis in anemic iron-replete Chinese CKD-5HD patients.

    Rockwell Medical signed exclusive licensing and manufacturing supply agreements in 2016 with Wanbang Biopharmaceuticals for the rights to commercialize Triferic in China. Under the terms of the agreement, Wanbang Biopharmaceuticals became the exclusive distributor for Triferic in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. Wanbang Biopharmaceuticals is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In consideration for the exclusive rights, Rockwell received an upfront fee and is entitled to a regulatory approval milestone, revenue milestone payments, and Rockwell is entitled to receive ongoing earnings from product sales of Triferic and other additional Triferic therapeutic indications that Wanbang Biopharmaceuticals may develop. In addition to the hemodialysis indication, Wanbang Biopharmaceuticals has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang Biopharmaceuticals is responsible for all clinical, regulatory and marketing expenses for Triferic in China as well as development and regulatory costs for new Triferic indications. Rockwell retains manufacturing responsibility of all products.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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. Rockwell Medical's exclusive renal drug therapies, Triferic (ferric pyrophosphate citrate) Dialysate and Triferic AVNU, are the only FDA-approved therapeutics indicated for 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 replace the ongoing losses to maintain hemoglobin without increasing iron stores. Both formulations donate iron immediately and completely to transferrin (carrier of iron in the body), which is then transported to the bone marrow to be incorporated into hemoglobin. Because of this unique mechanism of action, there is no increase in ferritin (a measure of stored iron). Triferic and Triferic AVNU address a significant medical need in treating Functional Iron Deficiency in end-stage kidney disease patients.

    The safety profile of Triferic is similar to placebo in controlled clinical trials in patients with end-stage kidney disease. Since approval, there have been no safety related changes to the product labeling.

    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. Importantly, there have been no reports of anaphylaxis in over 1.2 million patient administrations.

    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, the impact of COVID-19 on Rockwell Medical's business and operations, patient enrollment in a clinical trial and regulatory filings in China, the success of Triferic Dialysate and Triferic AVNU within clinical trials, the commercialization of Triferic Dialysate and Triferic AVNU in China, the potential approval of Triferic and Triferic AVNU in China, potential future sales within China and anticipated market sizes and future growth, future milestone payments and reliance upon approval and sales, and the development plans and timing for Rockwell Medical's FPC pipeline candidates in new indications. 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 impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results, including our supply chain, and the ability to enroll patients in clinical trials, the ability to have governmental agencies review submissions in a timely manner, and the ability to commercialize Triferic and Triferic AVNU; the potential for modifications of regulatory requirements in both internationally and domestically; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate and Triferic AVNU; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of the development of our FPC pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; 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 September 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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  4. WIXOM, Mich., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will record a presentation at H.C. Wainwright BioConnect 2021 Conference. This presentation will become publicly available on January 11, 2021, at 6:00 a.m. ET and will be archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming…

    WIXOM, Mich., Jan. 05, 2021 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will record a presentation at H.C. Wainwright BioConnect 2021 Conference. This presentation will become publicly available on January 11, 2021, at 6:00 a.m. ET and will be archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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%).

    Triferic® is a registered trademark of Rockwell Medical, Inc. Triferic AVNU is pending with the U.S. Patent and Trademark Office. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

     



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  5. WIXOM, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the appointment of industry leader and renowned life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors, effective December 11, 2020. Ms. Smiley currently serves as President and Chief Executive Officer of VMS BioMarketing and is a member of the Board of Directors of life science company, Assertio (formerly Zyla Life Sciences).

    "We are pleased to welcome Andrea to the Board of Directors," said John…

    WIXOM, Mich., Dec. 16, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced the appointment of industry leader and renowned life science industry executive, Ms. Andrea Heslin Smiley, to its Board of Directors, effective December 11, 2020. Ms. Smiley currently serves as President and Chief Executive Officer of VMS BioMarketing and is a member of the Board of Directors of life science company, Assertio (formerly Zyla Life Sciences).

    "We are pleased to welcome Andrea to the Board of Directors," said John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical. "Andrea brings a wealth of experience in patient adherence and outcomes, clinical educator solutions, nursing networks, and pharmaceutical product launches and marketing. She will be a valuable advisor in maximizing the value of Triferic® in kidney disease and our FPC technology in home infusion and heart failure."

    "I am delighted to join Rockwell Medical's Board of Directors at this exciting time for the Company, especially as we plan to move into the rapidly growing home infusion market," said Ms. Smiley.

    Ms. Smiley brings approximately three decades of commercialization and general management experience in the biopharmaceutical industry in both public and private companies. She joined VMS BioMarketing, a leading provider of patient and healthcare provider support, in 2008, and has served as its President and Chief Executive Officer since 2011. Within her first year as CEO, she spun-off commoditized business units and focused the company on impacting patient adherence and outcomes, all the while establishing VMS BioMarketing as the leading provider and growth leader of clinical nurse educator patient support solutions. Prior to joining VMS BioMarketing, Ms. Smiley spent 18 years at Eli Lilly and Company in various positions of increasing responsibility in finance, business development, corporate affairs, brand management and business unit leadership roles. She was the marketing leader for the launch of Humalog® Mix75/25™, she led sales and marketing for Humatrope®, she was responsible for the development and launch of Forteo® and she was the business unit leader of Lilly's women's health business, among other programs. Earlier in her career, Ms. Smiley worked as a management consultant for Putnam Associates, where she led consulting teams and advised brands in the biotechnology, pharmaceutical and managed healthcare fields on product launches and access strategies. She is a regular speaker and panel member on patient adherence, patient services and women's leadership topics at biopharmaceutical industry conferences. Ms. Smiley serves on the board of numerous nonprofit organizations including the Indiana Alzheimer's Association, Summer Stock, Indiana Salvation Army and the Lung Force Women's Cabinet. She received a gubernatorial appointment to the Indiana Commission for Women. Ms. Smiley earned her Bachelor of Arts degree in economics from DePauw University, where she was an Honors Management Fellow.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, the development plans and timing for Rockwell Medical's FPC pipeline candidates including but not limited to the potential application of FPC within the home infusion market, and the commercialization of future FPC pipeline candidates in other therapeutic areas. 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 impact of the COVID-19 pandemic (including, applicable federal state or local orders) on business and operating results and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended September 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902



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  6. -Ended the quarter with $67.3 million in cash, cash equivalents and investments-

    -Q3 2020 revenue of $15.3 million-

    -U.S. commercial launch of Triferic® AVNU expected in Q1 2021-

    -Poised to enroll first patient in Phase 3 clinical trial of Triferic in China-

    -Unveiled plans to develop FPC platform in new indications-

    WIXOM, Mich., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended September 30, 2020.

    "Rockwell Medical is…

    -Ended the quarter with $67.3 million in cash, cash equivalents and investments-

    -Q3 2020 revenue of $15.3 million-

    -U.S. commercial launch of Triferic® AVNU expected in Q1 2021-

    -Poised to enroll first patient in Phase 3 clinical trial of Triferic in China-

    -Unveiled plans to develop FPC platform in new indications-

    WIXOM, Mich., Nov. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended September 30, 2020.

    "Rockwell Medical is sufficiently capitalized to drive value creation now, in the near-term and into the future, and we are working across three tracks concurrently: maximizing U.S. sales of Triferic and soon-to-be-launched Triferic AVNU; expanding the global commercial reach of Triferic through our key partners; and strategically developing new indications for our FPC platform," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "I am pleased to report that we have made important progress across all three tracks in the third quarter of 2020."

    Third Quarter 2020 Operational Highlights

    U.S. Sales - Triferic Dialysate and Concentrates

    • Net sales for the concentrates business were $15.0 million and net sales for Triferic were $0.3 million in the third quarter of 2020.



    • There were approximately 3,400 contracted patients on therapy in the third quarter, representing approximately 500,000 annualized treatments.



    • Rockwell continues to implement appropriate COVID-19 precautions to reduce the risk of possible exposure to employees. The Company has experienced no material impact on its supply chain to date. The Company continued to experience an impact on its sales and marketing efforts for Triferic Dialysate due to the restrictions put in place because of COVID-19.

    Triferic AVNU – United States

    • Rockwell Medical expects to commercially launch Triferic AVNU in the United States in Q1 2021. Triferic AVNU will be reimbursed within the End Stage Renal Disease ("ESRD") bundle payment that has been established for Medicare patients.

    Triferic – Global Development and Commercialization

    • Wanbang Biopharmaceutical, Rockwell's partner in China, is poised to enroll the first patient in a pivotal Phase 3 trial for Triferic in China to support a filing for regulatory approval. Hemodialysis in China has continued to increase at a rapid rate in recent years, with over 600,000 hemodialysis patients in China, making it the largest single market in the world.



    • Sun Pharma, Rockwell's partner in India, submitted all regulatory appeal process documents to the Indian Central Drugs Standard Control Organization's Technical Committee. Sun Pharma is navigating next steps due to the country's temporary suspension of regulatory review due to COVID-19. India is a potentially attractive market for Triferic, with over 120,000 hemodialysis patients.



    • In September 2020, Rockwell Medical entered into an exclusive license agreement with Jeil Pharmaceutical Co., Ltd. ("Jeil"), for the rights to commercialize Triferic in South Korea. Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea. In consideration for the license, Rockwell Medical received an upfront fee of $200,000 and will be eligible for milestone payments and royalties on net sales. South Korea represents a sizable and growing market opportunity, with over 78,000 patients receiving hemodialysis annually.

    New Indications for Ferric Pyrophosphate Citrate ("FPC") Platform:

    • In September 2020, the Rockwell Medical management team, in conjunction with leading key opinion leaders ("KOLs"), announced the Company's growth plan and new therapeutic opportunities for its FPC platform:



      ○ The Company's priority new indication to pursue is FPC for the treatment of iron deficiency in patients requiring home infusion therapy, a rapidly growing area of medicine, with more than 3.2 million patients served in 2019. Iron deficiency anemia ("IDA") is a common co-morbidity in many sub-groups of patients receiving home infusion therapy, particularly in those receiving long-term home parenteral nutrition ("HPN"). Rockwell Medical believes that FPC is uniquely suited for the treatment of IDA in the home infusion population based upon its kinetic profile and outstanding safety profile in both clinical trials and post-marketing use, and may fill an unmet clinical need as a uniquely suitable home infusion therapy for treatment of IDA. Rockwell Medical intends to hold a Type C meeting with the FDA in Q1 2021 to discuss the pathway for clinical development and anticipates conducting a Phase II observational study and a dose scheduling study to achieve proof-of-concept, with data expected to report around the end of 2021.



      ○ The Company is evaluating the potential of FPC to improve cardiac function in hospitalized acute heart failure patients. Heart failure in the U.S. has a large and growing patient population, with more than one million patients hospitalized each year with acute decompensated heart failure; iron deficiency ("ID") is a common co-morbidity.

    Third Quarter 2020 Corporate Updates

    • In September 2020, Rockwell Medical appointed Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer and Chief Business Officer. Mr. Skibsted is a seasoned executive with more than 25 years of experience in finance, global business development, capital raising, investor relations, and operations. He has worked with a variety of both public and private life sciences companies, from commercial stage, development stage and start up.

    Third Quarter 2020 Selected Financial Highlights

    The following discussion and analysis should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2020.

    Net sales for the third quarter of 2020 were $15.3 million, a decrease of 0.8% compared to net sales of $15.4 million for the third quarter of 2019. The decrease was primarily due to a decrease in international sales of our dialysis concentrates products. Triferic net sales for the three months ended September 30, 2020, were approximately $0.3 million. Triferic was launched in Q2 2019 via the sample evaluation program and there were nominal revenues during the three months ended September 30, 2019.

    Cost of sales for the third quarter of 2020 was $14.9 million, resulting in gross profit of $0.3 million, compared to cost of sales of $15.4 million and a nominal gross loss during the third quarter of 2019. Gross profits are primarily related to our concentrates business at this time.

    Selling and marketing expenses were $1.7 million for the third quarter of 2020 compared to $1.8 million for the third quarter of 2019.

    General and administrative expenses were $3.6 million for the third quarter of 2020 compared to $4.6 million for the third quarter of 2019. The decrease of $1.0 million was primarily due to a decrease in incentive compensation from forfeited equity awards associated with the departure of our former Chief Financial Officer in July 2020, a decrease in consulting expense relating to strategic development, a decrease in accounting costs relating to a decrease in internal audit fees; partially offset by severance pay related to our former President and Chief Executive Officer.

    Research and product development expenses were $1.7 million for the third quarter of 2020 compared to $1.5 million for the third quarter of 2019. The increase in costs relate to our scientific programs. The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our FPC technology platform.

    Net loss for the third quarter of 2020 was $7.4 million, or $0.10 per basic and diluted share, compared to a net loss for third quarter of 2019 of $7.9 million, or $0.12 per basic and diluted share.

    Cash, cash equivalents, and investments available-for-sale totaled $67.3 million as of September 30, 2020, compared to $40.0 million on June 30, 2020. Working capital was $65.2 million as of September 30, 2020, compared to $40.0 million as of June 30, 2020.

    On September 25, 2020, Rockwell Medical closed a registered direct offering of 23,178,809 of its shares of common stock (or common stock equivalents in lieu thereof) and short-term warrants to purchase up purchase up to an aggregate of 23,178,809 shares of common stock to several healthcare-focused and other institutional investors. The gross proceeds from the registered direct offering were $35.0 million before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds to advance the development of FPC, currently indicated for the maintenance of hemoglobin in dialysis, in new indications, including for the treatment of anemia in the home infusion setting, as well as for working capital and general corporate purposes.

    Additionally, the Company has a debt facility of $35.0 million of which the first tranche of $22.5 million was funded in March 2020 and is classified as long-term debt on the balance sheet. The Company may 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.

    As of September 30, 2020, there were 93,573,165 shares of common stock outstanding versus 70,156,922 shares outstanding as of June 30, 2020.

    Third Quarter 2020 and Business Update Conference Call and Webcast

    Rockwell Medical's management team will host a conference call and audio webcast today at 4:30 p.m. ET to discuss Q3 2020 financial results and provide a business update.

    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 7679074. 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 iron deficiency and 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, the impact of COVID-19 on Rockwell Medical's business and operations, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, expected reimbursement for Triferic AVNU, the development plans and timing for Rockwell Medical's FPC pipeline candidates, the patient enrollment in a clinical trial and regulatory filings in China, regulatory approval in India and estimated market sizes. 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 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; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate; the success and timing of our commercial launch of Triferic AVNU in the United States; the success and timing of the development of our FPC pipeline candidates, the risk that topline clinical data and real world results may not be predictive of future results; 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 September 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    Financial Tables Follow

     
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Balance Sheets
    (Dollars in Thousands)
        
     September 30, 2020 December 31, 2019
     (Unaudited)  
    ASSETS   
    Cash and Cash Equivalents$56,614  $11,794 
    Investments Available-for-Sale 10,702   14,250 
    Accounts Receivable, net 4,129   4,203 
    Inventory, net 3,877   3,647 
    Prepaid and Other Current Assets 2,621   2,980 
    Total Current Assets 77,943   36,874 
    Property and Equipment, net 2,785   2,433 
    Inventory, Non-Current 859   441 
    Right of Use Assets, net 2,099   3,213 
    Goodwill 921   921 
    Other Non-Current Assets 629   435 
    Total Assets$ 85,236  $ 44,317 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Accounts Payable$4,190  $3,018 
    Accrued Liabilities 4,968   4,518 
    Settlement Payable -   104 
    Lease Liability - Current 1,155   1,493 
    Deferred License Revenue - Current 2,180   2,234 
    Insurance Financing Note Payable -   763 
    Customer Deposits 73   55 
    Other Current Liability - Related Party 142   188 
    Total Current Liabilities 12,708   12,373 
        
    Lease Liability - Long-Term 1,039   1,781 
    Term Loan, Net of Issuance Costs 20,856   - 
    Deferred License Revenue - Long-Term 8,558   9,843 
    Total Liabilities 43,161   23,997 
        
        
    Stockholders' Equity:   
    Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; no shares issued and outstanding at September 30, 2020 and December 31, 2019 -   - 
    Common Stock, $0.0001 par value; 170,000,000 shares authorized; 93,573,165 and 65,378,890 shares issued and outstanding at September 30, 2020 and December 31, 2019, respectively 9   7 
    Additional Paid-in Capital 370,760   326,777 
    Accumulated Deficit (328,743)  (306,516)
    Accumulated Other Comprehensive Income 49   52 
    Total Stockholders' Equity 42,075   20,320 
    Total Liabilities and Stockholders' Equity$ 85,236  $ 44,317 
        



     
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Statements of Operations
    (Unaudited)
            
    In thousands of US dollars ($) except per share amountsThree Months Ended September 30, 2020 Three Months Ended September 30, 2019 Nine Months Ended September 30, 2020 Nine Months Ended September 30, 2019
            
    Net Sales$15,280  $15,407  $47,033  $45,812 
    Cost of Sales 14,934   15,424   44,693   44,085 
    Gross Profit 346   (17)  2,340   1,727 
    Selling and Marketing 1,669   1,827   5,738   7,149 
    General and Administrative 3,622   4,623   11,767   16,341 
    Settlement Expense -   -   -   430 
    Research and Product Development 1,745   1,475   5,183   4,930 
    Operating Loss (6,690)  (7,942)  (20,348)  (27,123)
            
    Other Income (Expense)       
    Realized Gain on Investments 4   6   8   24 
    Warrant Modification Expense -   -   (837)  - 
    Interest Expense (666)  (16)  (1,289)  (16)
    Interest Income 2   97   239   289 
    Total Other Income (660)  87   (1,879)  297 
            
    Net Loss$(7,350) $(7,855) $(22,227) $(26,826)
            
    Basic and Diluted Net Loss per Share$(0.10) $(0.12) $(0.32) $(0.45)
    Basic and Diluted Weighted Average Shares Outstanding 71,811,322   63,796,723   69,594,167   59,728,446 
            

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

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  7. WIXOM, Mich., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, November 9, 2020, at 4:30 p.m. ET to discuss its financial results for the three months ended September 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 7679074. A live webcast of the call will be available under "Events…

    WIXOM, Mich., Oct. 27, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, today announced that it will host a conference call on Monday, November 9, 2020, at 4:30 p.m. ET to discuss its financial results for the three months ended September 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 7679074. 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.

    To submit questions in advance, please email your questions to .

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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 1,200,000 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%).

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  8. WIXOM, Mich., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that two abstracts have been accepted for poster presentation at the American Society of Nephrology (ASN) Virtual Kidney Week 2020, which will occur from October 20 to 25, 2020.

    Title: Use of Triferic and Outcomes of HDD Patients: Initial Analysis Using 2016-2017 USRDS
    Presenter: Yi Zhang, Ph.D., Sr. Research Associate, Medical Technology and Practice Patterns Institute
    Session Title: Hemodialysis and Frequent Dialysis - 4
    E-Poster Number: PO1213…

    WIXOM, Mich., Oct. 13, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that two abstracts have been accepted for poster presentation at the American Society of Nephrology (ASN) Virtual Kidney Week 2020, which will occur from October 20 to 25, 2020.

    Title: Use of Triferic and Outcomes of HDD Patients: Initial Analysis Using 2016-2017 USRDS

    Presenter: Yi Zhang, Ph.D., Sr. Research Associate, Medical Technology and Practice Patterns Institute

    Session Title: Hemodialysis and Frequent Dialysis - 4

    E-Poster Number: PO1213

    Abstract Number: 3450928

    Title: Triferic (ferric pyrophosphate citrate, FPC) Maintains Hemoglobin and Reduces IV Iron: Results from a Single-site 2 Year Observational Analysis

    Presenter: Marc Hoffman, M.D., Chief Medical Officer, Rockwell Medical

    Session Title: Anemia and Iron Management

    E-Poster Number: PO0225

    Abstract Number: 3440944

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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 1,200,000 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, statements relating to the abstract accepted for poster presentations. 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: market and other conditions, the impact of the COVID-19 pandemic (including federal or state orders) on business and operating results; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended June 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  9. -New indications for FPC platform provide significant growth opportunity-

    -Anticipates Type C meeting with FDA for home infusion in Q1 2021 and for acute heart failure in 2H 2021-

    -Well capitalized to fund dialysis business and advance clinical development for home infusion indication-

    -Archived webcast available on corporate website-

    WIXOM, Mich., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, earlier today concluded its Management and Key Opinion Leader (KOL) conference…

    -New indications for FPC platform provide significant growth opportunity-

    -Anticipates Type C meeting with FDA for home infusion in Q1 2021 and for acute heart failure in 2H 2021-

    -Well capitalized to fund dialysis business and advance clinical development for home infusion indication-

    -Archived webcast available on corporate website-

    WIXOM, Mich., Sept. 24, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and iron deficiency anemia management and improving outcomes for patients around the world, earlier today concluded its Management and Key Opinion Leader (KOL) conference call and webcast to discuss potential novel indications for its ferric pyrophosphate citrate (FPC) platform. The conference call included presentations by Rockwell Medical executive management and Connie Sullivan, B.S. Pharm., President and CEO of the National Home Infusion Association, and Inder Anand, M.D., F.R.C.P., D.Phil. (Oxon), Emeritus Professor of Medicine at the University of Minnesota Medical School and Former Director of the Heart Failure Program at VA Medical Center in Minneapolis.

    "Earlier today, Rockwell Medical and independent leading experts laid out the pathway for potential important value creation for the Company through the development of the FPC platform to treat medical conditions with unmet clinical needs outside of the hemodialysis setting. This exciting new development plan for FPC, along with increasing adoption of Triferic for dialysis patients, are evidence of Rockwell Medical's continued focus on our vision – to transform the treatment of iron deficiency and anemia for the millions of people affected worldwide," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "FPC for the treatment of iron deficiency anemia (IDA) in home infusion patients is our top development priority, which we view as a tractable clinical development project with relatively low safety risk given our extensive safety database of FPC, and low efficacy risk given our expertise and experience in the use of parenteral iron for the treatment of IDA. We expect to hold a Type C meeting with the U.S. Food and Drug Administration (FDA) in the first quarter of 2021 to discuss the program further. We are well capitalized to fund our existing dialysis business and advance clinical development for a home infusion indication, and we expect opportunities for multiple data read-outs and milestone reports from the home infusion program over the next three years as we advance the program through Phase II clinical proof-of-concept development."

    Dr. Ellison added: "In addition, we discussed potentially pursuing an indication for FPC in hospitalized patients with acute heart failure. We believe FPC could be uniquely suited for these patients, based upon a completed mechanistic proof-of-concept study and the immediately bioavailable iron that FPC can deliver to patients during a short hospital stay. We continue to evaluate this opportunity and anticipate holding a Type C meeting with the FDA in the second half of 2021 to discuss the pathway for a potential clinical development program."

    Highlights from the conference call and webcast are as follows:

    Home Infusion

    • Home infusion therapy is a rapidly growing area of medicine, with over 3.2 million patients served in 2019. We believe the growth trend is likely to continue driven by cost savings versus office-based or hospital care, an improving reimbursement landscape, and emerging standards resulting from the COVID-19 pandemic.
    • IDA is a common co-morbidity in many sub-groups of patients receiving home infusion therapy, particularly in those receiving long-term home parenteral nutrition (HPN).
    • Management of IDA in home infusion patients is currently a ‘broken' process, according to the National Home Infusion Association, due to limitations with currently available parenteral iron products and other factors.
    • FPC is uniquely suited for the treatment of IDA in the home infusion population based upon its kinetic profile and outstanding safety profile in both clinical trials and post-marketing use, and may fill an unmet clinical need as a uniquely suitable home infusion therapy for treatment of IDA.
    • Home infusion therapy patients with IDA may be candidates for treatment with FPC across additional therapeutic categories besides HPN. These categories include antineoplastic chemotherapy, hydration therapy, inotropics and biologics. The U.S. market opportunity for HPN is estimated to be $200 million per year, and the U.S. market opportunity for the other categories above is estimated to be $400 million per year.
    • The majority of home infusion therapy patients are covered by commercial insurance, and payers are increasingly motivated to reimburse home infusions to reduce in-office visits and hospitalizations, and save costs.
    • Rockwell Medical intends to hold a Type C meeting with the FDA in Q1 2021 to discuss the pathway for clinical development. The Company anticipates conducting a Phase II observational study and a dose scheduling study to achieve proof-of-concept, with the goal of ultimately securing a broad label claim of treatment of IDA in adult patients receiving home infusion therapy regardless of etiology.
    • The Company expects Phase II data around the end of 2021.

    Acute Heart Failure

    • Heart failure (HF) in the U.S. is a large and growing patient population. More than one million patients are hospitalized each year with acute decompensated heart failure, and iron deficiency (ID) is a common co-morbidity in all forms of HF.
    • The acute heart failure (AHF) opportunity for FPC is associated with a large patient population with a high incidence of iron deficiency. FPC has theoretical acute clinical advantages (<30 days) vs. traditional IV iron therapy for iron deficient acute heart failure patients and could have an impact on hospital length of stay and/or 30-day readmissions.
    • The majority of heart failure patients admitted to the hospital are insured by Medicare/Medicaid through a well-established universal approach usually resulting in a bundled reimbursement structure.
    • Rockwell Medical intends to hold a Type C meeting with the FDA in the second half of 2021 to discuss a potential regulatory pathway. This meeting with the FDA will inform whether the Company ultimately pursues an indication in AHF.

    An archived webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, https://ir.rockwellmed.com/.

    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 (ferric pyrophosphate citrate injection), 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%).

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    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, potential new indication opportunities for Ferric Pyrophosphate Citrate ("FPC"), the potential for FPC to address the significant unmet need for home infusion patients, market opportunities for new indications, the clinical risk and safety profiles of new indications, the development of a clinical plan and timing of FDA review of FPC for new indications, the potential for reimbursement of FPC for new indications, the growth of the home and specialty infusion marketplace, the timing and success of regulatory filings for new indications, the timing and cost of clinical development plans and clinical study designs. 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 impact of the COVID-19 pandemic (including, applicable federal, state or local orders) on business and clinical development plans; the risk that regulatory authorities delay or fail to approve FPC for new indications; the risk that market opportunities are smaller than estimated; the risk that Rockwell Medical is not able to seek reimbursement for FPC for new indications; the risk that FPC is unsafe for new indications; the risk that clinical study designs, timing and costs are different than estimated; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended June 30, 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.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  10. WIXOM, Mich., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has entered into securities purchase agreements with several healthcare-focused and other institutional investors to purchase 23,178,809 of its shares of common stock (or common stock equivalents in lieu thereof) and short-term warrants to purchase up to an aggregate of 23,178,809 shares of common stock, in a registered direct offering priced at-the-market under Nasdaq rules.  The combined purchase price for one share of common stock…

    WIXOM, Mich., Sept. 23, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has entered into securities purchase agreements with several healthcare-focused and other institutional investors to purchase 23,178,809 of its shares of common stock (or common stock equivalents in lieu thereof) and short-term warrants to purchase up to an aggregate of 23,178,809 shares of common stock, in a registered direct offering priced at-the-market under Nasdaq rules.  The combined purchase price for one share of common stock (or common stock equivalent) and a warrant to purchase one share of common stock is $1.51. The warrants have an exercise price of $1.80 per share, will be immediately exercisable, and will expire 24 months from the issue date.

    H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

    The gross proceeds from the registered direct offering are expected to be approximately $35.0 million before deducting placement agent fees and other offering expenses. The Company intends to use the net proceeds to advance the development of ferric pyrophosphate citrate (FPC), currently indicated for the maintenance of hemoglobin in dialysis, in new indications, including for the treatment of anemia in the home infusion setting, as well as for working capital and general corporate purposes. The registered direct offering is expected to close on or about September 25, 2020, subject to the satisfaction of customary closing conditions.

    The securities described above are being offered pursuant to a "shelf" registration statement (File No. 333-227363) filed with the Securities and Exchange Commission (SEC) on September 14, 2018 and declared effective on October 1, 2018. Such securities may be offered only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A prospectus supplement and the accompanying prospectus relating to the offering of the securities will be filed with the SEC. Electronic copies of the prospectus supplement and the accompanying prospectus relating to the offering of the securities may be obtained, when available, on the SEC's website at http://www.sec.gov or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by e-mail: or by telephone: (646) 975-6996.

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor there any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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.

    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, statements related to our ability to close the offering, the gross proceeds from the offering and the use of proceeds. 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: market and other conditions, the impact of the COVID-19 pandemic (including, applicable federal, state or local orders) on business and operating results; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended June 30, 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. All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  11. WIXOM, Mich., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the appointment of Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer ("CFO") and Chief Business Officer ("CBO"), effective today, September 15, 2020. In this new role, Mr. Skibsted will be responsible for business development, financial operations and investor relations for the Company and will oversee the Finance and Accounting, Legal and Compliance, and Human Resources and Administration functions, reporting…

    WIXOM, Mich., Sept. 15, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the appointment of Russell L. Skibsted, M.B.A., as Executive Vice President, Chief Financial Officer ("CFO") and Chief Business Officer ("CBO"), effective today, September 15, 2020. In this new role, Mr. Skibsted will be responsible for business development, financial operations and investor relations for the Company and will oversee the Finance and Accounting, Legal and Compliance, and Human Resources and Administration functions, reporting to the Chief Executive Officer and Board of Directors.

    "We are pleased to announce Russell's appointment as CFO and CBO of Rockwell Medical. His more than two decades of life sciences industry executive experience, including roles as CFO and CBO of publicly-traded biotechnology companies, are an excellent match for our Company as we focus on transforming our business through executing our commercial and worldwide business development strategy for Triferic and Triferic AVNU in kidney dialysis, and prioritize the development potential of our FPC platform to address iron deficiency and iron deficiency anemia in other medical indications," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "Russell will be a dynamic contributor to our leadership team, and we warmly welcome him to the Company."

    "I am honored to join Rockwell Medical at this pivotal time for the Company and look forward to working with the executive team and other stakeholders to strategically advance the business and bring value to patients and stockholders," said Mr. Skibsted.

    Mr. Skibsted is a seasoned executive with more than 25 years of experience in finance, global business development, capital raising, investor relations, and operations. He has worked with a variety of both public and private life sciences companies, from commercial stage, development stage and start up. Prior to joining Rockwell, he served as CFO of AgeX Therapeutics (NYSE:AGE), a biotechnology company focused on cell therapy targeting the diseases of aging that was spun out of BioTime, Inc. (currently Lineage Cell Therapeutics, Inc. (NYSE American and TASE: LCTX)). Previously, Mr. Skibsted served as CFO of BioTime, Inc., a publicly-traded biotechnology company which he joined in 2015, where he simultaneously, from time to time, performed the role of Chief Financial Officer for several of BioTime's public and private subsidiaries, including Agex Therapeutics, OncoCyte Corporation (NYSE:OCX), a developer of novel, non-invasive tests for the early detection of cancer (November 2015 through November 2017) and Asterias Biotherapeutics, Inc., a biotechnology company pioneering the field of regenerative medicine with clinical programs in spinal cord injury and oncology immunotherapy (March 2016 through November 2016). Prior to BioTime, Mr. Skibsted served as CFO or Chief Business Officer for several public and private life science companies, including Proove Biosciences, Aeolus Pharmaceuticals, Spectrum Pharmaceuticals and Hana Biosciences. From time to time, he also acted as a consulting CFO to various life science companies as Managing Director of RSL Ventures. Earlier in his career, Mr. Skibsted held roles as Portfolio Management Partner and CFO at Asset Management Company, one of the oldest and most respected venture capital firms in Silicon Valley, and Vice President for GE Capital Services Structured Finance Group. Mr. Skibsted holds a B.A. in Economics from Claremont McKenna College and an M.B.A. from the Stanford Graduate School of Business.

    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%).

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    Notice of Issuance of Inducement Grants

    Pursuant to his employment agreement, Mr. Skibsted will be awarded stock-based compensation representing the right to acquire shares of common stock (the "Inducement Grants"). The Inducement Grants will consist of options to purchase up to 750,000 shares of common stock, subject to 600,000 of which are subject to time-based vesting conditions and 150,000 of which are subject to performance-based vesting conditions. The Inducement Grants will be issued upon Mr. Skibsted's commencement of employment (the "Grant Date"), and all stock options included within the Inducement Grants will have an exercise price equal to the fair value of the common stock on the Grant Date. The Inducement Grants have been approved by the Company's Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company's stockholder-approved equity incentive plans as an inducement grant, in accordance with Nasdaq Listing Rule 5635(c)(4).

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

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  12. WIXOM, Mich., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has entered into an exclusive license agreement with Jeil Pharmaceutical Co., Ltd. ("Jeil"), for the rights to commercialize Triferic (ferric pyrophosphate citrate) in South Korea.

    Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea and Rockwell Medical will supply the product to Jeil. In consideration for the license, Rockwell Medical will receive…

    WIXOM, Mich., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced that it has entered into an exclusive license agreement with Jeil Pharmaceutical Co., Ltd. ("Jeil"), for the rights to commercialize Triferic (ferric pyrophosphate citrate) in South Korea.

    Under the terms of the license agreement, Jeil will be the exclusive development and commercialization partner for Triferic in South Korea and Rockwell Medical will supply the product to Jeil. In consideration for the license, Rockwell Medical will receive an upfront fee and will be eligible for milestone payments and royalties on net sales.

    Jeil has developed and supplied pharmaceutical products and contributed to the growth and development of the pharmaceutical industry in Korea since its founding in 1959. Jeil, listed on the Korea Composite Stock Price (KOSPI) index since 1988, has approximately 1,000 employees and more than $576 million in sales for the year ended 2019.  Jeil will leverage its strong development and commercialization capabilities and local market expertise to promote Triferic to nephrologists in South Korea. A Joint Alliance Committee, comprised of members from Rockwell Medical and Jeil, will guide the development and execution for Triferic in South Korea. Jeil will be responsible for all regulatory and commercialization activities. Product sales are anticipated to begin in early 2022, subject to regulatory approval.

    "We are pleased to announce the license agreement with Jeil and the establishment of a relationship between our two companies," said Russell Ellison, M.D., President and Chief Executive Officer of Rockwell Medical. "With its substantial development and commercialization capabilities and local market expertise, Jeil is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic across South Korea. Today's news marks another meaningful advancement for Triferic, as we expand our global footprint and drive the long-term value of Triferic."

    "We welcome this opportunity to collaborate with Rockwell Medical to provide Triferic to patients on hemodialysis in South Korea," said Suk-Je Sung, President and Chief Execute Officer of Jeil. "There remains a significant unmet need for innovative medicine to address iron deficiency in these patients, with more than 78,000 patients receiving hemodialysis every year and we expect the number of CKD dialysis patients to continue to increase and double by 2030."

    Torreya Partners acted as a financial advisor to Rockwell Medical for this transaction.

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical company dedicated to transforming iron deficiency and 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, the receipt of an upfront fee and milestone payments and royalties by Rockwell Medical, the timing of product sales in South Korea, the receipt of regulatory approvals in South Korea and the potential market opportunity for Triferic in South Korea. 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 impact of the COVID-19 pandemic (including, applicable federal, state or local orders) on business and operating results; receipt of regulatory approval for Triferic in South Korea; our ability to achieve milestones and receive royalty payments; anticipated market opportunity in South Korea; and those risks more fully discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the period ended June 30, 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.  All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  13. WIXOM, Mich., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world,  today announced it will host a conference call and webcast on Thursday, September 24, 2020, at 4:30 p.m. ET to discuss potential novel applications of ferric pyrophosphate citrate (FPC), the active pharmaceutical ingredient in Triferic®, for the treatment of iron deficiency anemia in patients undergoing home infusion therapy and iron deficiency in patients with acute heart failure. The call and webcast will include representatives from Rockwell Medical as…

    WIXOM, Mich., Sept. 09, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world,  today announced it will host a conference call and webcast on Thursday, September 24, 2020, at 4:30 p.m. ET to discuss potential novel applications of ferric pyrophosphate citrate (FPC), the active pharmaceutical ingredient in Triferic®, for the treatment of iron deficiency anemia in patients undergoing home infusion therapy and iron deficiency in patients with acute heart failure. The call and webcast will include representatives from Rockwell Medical as well as key opinion leaders (KOLs) Connie Sullivan, B.S. Pharm, President and CEO of the National Home Infusion Association, and Inder Anand, M.D., F.R.C.P., D.Phil. (Oxon), Emeritus Professor of Medicine at the University of Minnesota Medical School and Former Director of the Heart Failure Program at VA Medical Center in Minneapolis.

    "My charge as CEO is to actualize the potential of our FPC technology, for patients and for shareholders," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "I believe there is potential for important value creation through the development of the FPC platform to treat medical conditions with unmet clinical needs outside of the hemodialysis setting. The team at Rockwell Medical and independent leading experts in the field look forward to providing a more fulsome update on the market potential and the clinical development plans, for such new potential indications on the conference call and webcast later this month."

    To access the conference call, please dial (888) 317-6003 (local) or (412) 317-6061 (international) at least 10 minutes prior to the start time and refer to conference ID 5330503. 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 (ferric pyrophosphate citrate injection), 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%).

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

     

    Primary Logo

    View Full Article Hide Full Article
  14. WIXOM, Mich., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will present at two upcoming investor conferences in September:

    Conference: H.C. Wainwright 22nd Annual Global Investment Conference
    Date: September 14, 2020
    Time: 4:00 PM EDT
    Location: Virtual

    Conference: Cantor Fitzgerald Virtual Global Healthcare Conference
    Date: September 15, 2020
    Time: 10:40 AM EDT
    Location:
    Virtual

    The presentations will be webcast live at the aforementioned time, and archived…

    WIXOM, Mich., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today announced the Rockwell Medical executive management team will present at two upcoming investor conferences in September:

    Conference: H.C. Wainwright 22nd Annual Global Investment Conference

    Date: September 14, 2020

    Time: 4:00 PM EDT

    Location: Virtual

    Conference: Cantor Fitzgerald Virtual Global Healthcare Conference

    Date: September 15, 2020

    Time: 10:40 AM EDT

    Location:
    Virtual

    The presentations will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    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%).

    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

      

    Media:

    David Rosen

    Argot Partners

    212.600.1902

      

    Primary Logo

    View Full Article Hide Full Article
  15. -Q2 2020 revenue of $15.9 million-

    -Increase in contracted clinics of 44 percent quarter-over-quarter-

    -Reached contracted annualized treatment volume for Triferic Dialysate of over 400,000-

    - $40.0 million in cash, cash equivalents and investments available-for-sale as of June 30, 2020-

    -Q2 2020 conference call and webcast scheduled for today at 4:30 p.m. ET-

    - Management/KOL conference call and webcast scheduled for September 24, 2020, to review our prioritization programs for new potential FPC indications-

    WIXOM, Mich., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management…

    -Q2 2020 revenue of $15.9 million-

    -Increase in contracted clinics of 44 percent quarter-over-quarter-

    -Reached contracted annualized treatment volume for Triferic Dialysate of over 400,000-

    - $40.0 million in cash, cash equivalents and investments available-for-sale as of June 30, 2020-

    -Q2 2020 conference call and webcast scheduled for today at 4:30 p.m. ET-

    - Management/KOL conference call and webcast scheduled for September 24, 2020, to review our prioritization programs for new potential FPC indications-

    WIXOM, Mich., Aug. 10, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients around the world, today reported financial results and a business update for the three months ended June 30, 2020.

    "In the second quarter, we continued to make important progress in the commercialization of Triferic Dialysate, despite the challenges of the COVID-19 pandemic. We significantly increased the number of clinics contracted to administer the therapy, and we reached the highest number of contracted patients on therapy and contracted annualized treatment volume since our launch," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "We continue to diligently prepare for a successful launch of Triferic AVNU in the United States later this year."

    "Importantly, we value the scientific underpinning of our ferric pyrophosphate citrate technology and the potential this represents in the treatment of iron deficiency and anemia. Approximately 10 million people are iron deficient in the United States, including 5 million who have iron deficiency anemia. We are committed to prudent medical and scientific advancements, and look forward to reviewing our programs for two therapeutic indications that, we believe, represent new opportunities to extend the innovative potential of our platform."

    Second Quarter 2020 Operational Highlights

    Triferic Dialysate

    • The Company signed contracts with 12 additional clinics during the second quarter of 2020, an increase of 44% in contracted clinics as compared to March 31, 2020. An additional eight clinics affiliated with a Medium-Sized Dialysis Organization (MDO) were trained and approved for adoption as of June 30, 2020. Substantially all clinics contracted within Q2 2020 signed and began purchasing in June 2020.

       
    • There were nearly 2,800 contracted patients on therapy as of June 30, 2020, representing more than 400,000 annualized treatments. This compares to nearly 2,000 contracted patients and over 300,000 annualized treatments as of March 31, 2020.

       
    • The Company, as of June 30, 2020, has active or committed Evaluation Programs with independent dialysis clinics and small and medium dialysis chains representing nearly 1,500 patients and 26 clinics.

       
    • Triferic net sales were $0.2 million in the second quarter of 2020.

       
    • Additional clinics were enrolled in the Company's Real World Data program.

       
    • The Company received regulatory approval for Triferic Dialysate in Chile in June 2020.

       
    • China's National Medical Products Administration (NMPA) approved the protocol for a clinical trial of Triferic Dialysate, to be initiated by its licensee in China, Wanbang Biopharmaceutical, Co., Ltd.

       
    • With respect to the COVID-19 pandemic, the Company continues to implement appropriate precautions to reduce the risk of possible exposure by restricting employee travel, adopting new preventative safety measures within its manufacturing facilities, instituting a work-from-home policy for substantially all employees, excluding its essential manufacturing and distribution employees, and leveraging virtual technology for the sales force to use in its communications with customers. The Company has experienced no material impact on its supply chain to date and has experienced an increase in demand for its dialysis concentrates products, believed to be attributed to customers building safety stock and international demand. Additionally, we have experienced an impact in our sales and marketing efforts for Triferic Dialysate due to the restrictions put in place because of COVID-19. This caused us to change the way we interact with our current and potential customers. We intend to initiate a sample evaluation program for Triferic AVNU during the third quarter of 2020 in order to prepare for a commercial launch. We will monitor the evaluation program in relation to the COVID-19 pandemic through the balance of the year.

    Triferic AVNU (I.V. Formulation)

    • The Company filed a New Drug Submission ("NDS") for Triferic AVNU in Canada in May 2020. Health Canada accepted the NDS in June 2020. The Company currently expects regulatory approval in mid-2021.

       
    • The Company continues to execute its commercial strategy to leverage the experience gained from the 2019 launch of Triferic Dialysate and lay the groundwork for the commercial introduction of Triferic AVNU. The Company currently expects to launch evaluation programs during the third quarter of 2020 to allow clinics to gain direct experience with Triferic AVNU, and expects Triferic AVNU to be available commercially during the fourth quarter of 2020, following the completion of the initial evaluation programs.

    New Indications for FPC

    • In the second quarter of 2020, and based upon analysis of development considerations, economics, pricing, and regimen ergonomics, the Company identified two new potential indications for its Ferric Pyrophosphate Citrate ("FPC") platform:

       
      • FPC for the treatment of iron deficiency in patients requiring home infusion therapy, which the Company considers its first priority new indication to pursue; and

         
      • FPC to improve cardiac function in hospitalized acute congestive heart failure patients, which is under consideration by the Company.

         
    • The Company plans to host a Management and KOL update conference call and webcast on Thursday, September 24, 2020, to discuss further details of its plans to pursue new FPC indications. The Company will provide additional details on accessing the conference call and webcast in the near future.

    Second Quarter 2020 Corporate Updates

    • In June 2020, the Board of Directors appointed industry leader and renowned authority on kidney disease, Allen R. Nissenson, M.D., F.A.C.P., to serve as a director. Dr. Nissenson serves as an Emeritus Professor of Medicine at the David Geffen School of Medicine at University California Los Angeles, Emeritus Chief Medical Officer of DaVita Kidney Care, and a member of the board of directors of Angion Biomedica Corp.

    Second Quarter 2020 Selected Financial Highlights

    The following discussion and analysis should be read in conjunction with our condensed consolidated financial statements and related notes on Form 10-Q for the second quarter ended June 30, 2020.

    Net sales for the second quarter of 2020 were $15.9 million, an increase of 7.1% compared to net sales of $14.8 million for the second quarter of 2019. The increase was primarily due to an increased demand for our dialysis concentrates products. Triferic net sales for the three months ended June 30, 2020 was approximately $0.2 million. Triferic was launched in Q2 2019 via the sample evaluation program and there were nominal revenues for the same period in 2019.

    Cost of sales for the second quarter of 2020 was $15.0 million, resulting in gross profit of $0.9 million, compared to cost of sales of $14.1 million and a gross profit of $0.7 million during the second quarter of 2019. Gross profits are primarily related to our Dialysis concentrates products at this time. The Company anticipates that potential future sales of Triferic will impact the mix on our future gross profits.

    Selling and marketing expenses were $2.0 million for the second quarter of 2020 compared to $2.2 million for the second quarter of 2019. The Company has invested in a specialty commercial team and marketing programs to support the launch of Triferic in Q2 of 2019 and the commercial introduction to Triferic AVNU.

    General and administrative expenses were $2.9 million for the second quarter of 2020 compared to $5.5 million for the second quarter of 2019. The decrease of $2.6 million was primarily due to a decrease in incentive compensation from forfeited equity awards associated with the departure of our former President and Chief Executive Officer in April 2020, a decrease in legal expense relating to previous litigation that has since been resolved; partially offset by severance pay relating to the same former President and Chief Executive Officer.

    Research and product development expenses were $1.6 million for the second quarter of 2020 compared to $3.0 million for the second quarter of 2019. The decrease of $1.4 million was due primarily to the payment for the Triferic AVNU NDA application fee of $1.3 million in Q2 2019. The Company is continuing to invest in its medical and scientific programs to support the global launch of Triferic and the advancement of our ferric pyrophosphate citrate technology platform.

    Net loss for the second quarter of 2020 was $6.9 million, or $0.10 per basic and diluted share, compared to a net loss for first quarter of 2019 of $10.3 million, or $0.18 per basic and diluted share.

    Cash, cash equivalents, and investments available-for-sale totaled $40.0 million as of June 30, 2020, compared to $48.9 million on March 31, 2020. Working capital was $40.0 million as of June 30, 2020 compared to $46.1 million as of March 31, 2020. Additionally, the Company has a debt facility of $35.0 million of which the first tranche of $22.5 million was funded in March 2020 and is classified as long-term debt on the balance sheet. The Company will be eligible to draw on a second and third tranche of $5.0 million and $7.5 million, respectively, upon achievement of certain milestones. Lastly, the Company has an at-the-market equity offering facility of $40.0 million of which approximately $32.6 million remains available for issuance under its at-the-market equity offering facility, pursuant to which the Company may sell, at such times and amounts as it deems appropriate, shares of common stock to support its business plan, subject to certain restrictions on use.

    As of June 30, 2020, there were 70,156,922 shares of common stock outstanding versus 69,049,102 shares outstanding as of March 31, 2020.

    Second Quarter 2020 and Business Update Conference Call and Webcast

    Rockwell Medical's management team will host a conference call and audio webcast today at 4:30 p.m. ET to discuss Q2 2020 financial results and provide a business update.

    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 iron deficiency and 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, the impact of COVID-19 on Rockwell Medical's business and operations, the commercialization of Triferic Dialysate, the launch of Triferic AVNU, the selection of and plans for Rockwell Medical's FPC pipeline candidates, the initiation of a clinical trial in China, the timeline for receipt of a target action date in Canada and the Company's expected research and development expenses. 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 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; the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate; the success and timing of international clinical trials for Triferic Dialysate; the  success and timing of our evaluation program for Triferic AVNU and our commercial launch of Triferic AVNU in the United States; the success and timing of the development of our FPB pipeline candidates, 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; anticipated research and development expenses, 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 June 30, 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.  All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    Financial Tables Follow



    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Balance Sheets
    (Unaudited)
        
     June 30, 2020 December 31, 2019
     (Unaudited)  
    ASSETS   
    Cash and Cash Equivalents$26,697,063  $11,794,526 
    Investments Available-for-Sale 13,258,197   14,250,176 
    Accounts Receivable, net 3,565,292   4,202,725 
    Inventory, net 4,557,177   3,646,906 
    Prepaid and Other Current Assets 3,458,104   2,979,504 
    Total Current Assets 51,535,833   36,873,837 
    Property and Equipment, net 2,306,462   2,433,405 
    Inventory, Non-Current 821,000   441,000 
    Right of Use Assets, net 2,440,115   3,212,530 
    Goodwill 920,745   920,745 
    Other Non-Current Assets 560,588   434,935 
    Total Assets$ 58,584,743  $ 44,316,452 
    LIABILITIES AND STOCKHOLDERS' EQUITY   
    Accounts Payable$3,313,240  $3,018,424 
    Accrued Liabilities 4,437,080   4,517,732 
    Settlement Payable -   104,000 
    Lease Liability - Current 1,342,228   1,493,394 
    Deferred License Revenue - Current 2,174,626   2,233,640 
    Insurance Financing Note Payable -   763,422 
    Customer Deposits 38,273   55,100 
    Other Current Liability - Related Party 189,600   187,849 
    Total Current Liabilities 11,495,047   12,373,561 
        
    Lease Liability - Long-Term 1,204,210   1,780,626 
    Term Loan, Net of Issuance Costs 20,764,213   - 
    Deferred License Revenue - Long-Term 8,909,703   9,842,762 
    Total Liabilities 42,373,173   23,996,949 
        
        
    Stockholders' Equity:   
    Preferred Stock, $0.0001 par value, 2,000,000 shares authorized; no shares issued and outstanding at June 30, 2020 and December 31, 2019 -   - 
    Common Stock, $0.0001 par value; 170,000,000 shares authorized; 70,156,922 and 65,378,890 shares issued and outstanding at June 30, 2020 and December 31, 2019, respectively 7,017   6,538 
    Additional Paid-in Capital 337,551,385   326,777,250 
    Accumulated Deficit (321,392,548)  (306,516,265)
    Accumulated Other Comprehensive Income 45,716   51,980 
    Total Stockholders' Equity 16,211,570   20,319,503 
    Total Liabilities and Stockholders' Equity$ 58,584,743  $ 44,316,452 
        





    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    (Unaudited)
            
     Three Months Ended

    June 30, 2020
     Three Months Ended

    June 30, 2019
     Six Months Ended

    June 30, 2020
     Six Months Ended

    June 30, 2019
            
    Net Sales$15,895,971  $14,845,788  $31,752,510  $30,405,227 
    Cost of Sales 15,015,404   14,112,639   29,759,017   28,661,686 
    Gross Profit 880,567   733,149   1,993,493   1,743,541 
    Selling and Marketing 1,996,595   2,218,997   4,069,393   5,321,375 
    General and Administrative 2,871,013   5,496,670   8,144,445   11,717,169 
    Settlement Expense -   430,000   -   430,000 
    Research and Product Development 1,616,393   2,958,276   3,437,881   3,455,552 
    Operating Loss (5,603,434)  (10,370,794)  (13,658,226)  (19,180,555)
            
    Other Income (Expense)       
    Realized Gain on Investments 2,065   4,135   3,994   18,023 
    Warrant Modification Expense (837,322)  -   (837,322)  - 
    Interest Expense (520,604)  -   (622,556)  - 
    Interest Income 66,750   74,476   237,827   192,002 
    Total Other Income (1,289,111)  78,611   (1,218,057)  210,025 
            
    Net Loss$(6,892,545) $(10,292,183) $(14,876,283) $(18,970,530)
            
    Basic and Diluted Net Loss per Share$(0.10) $(0.18) $(0.22) $(0.33)
    Basic and Diluted Weighted Average Shares Outstanding 69,428,574   58,216,066   68,473,407   57,660,947 
            

     

    CONTACTS

    Investors:

    Argot Partners

    212.600.1902

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  16. WIXOM, Mich., Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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…

    WIXOM, Mich., Aug. 03, 2020 (GLOBE NEWSWIRE) -- 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

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
    • Experienced healthcare industry executive with 35 years of experience
    • Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products

    Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer. Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005779/en/

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and…

    • Experienced healthcare industry executive with 35 years of experience
    • Additions to the board of directors to support the company's advancing its lead program, NTX-001, along with its pipeline products

    Neuraptive Therapeutics, Inc. (Neuraptive), a clinical-stage biotechnology company dedicated to developing novel therapeutics and medical products for the treatment of peripheral nerve injuries (PNI), today announced the hiring of Robert (Bob) S. Radie as Chief Executive Officer. Mr. Radie also will serve as Chairman of Neuraptive's Board of Directors.

    This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200623005779/en/

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    Robert Radie joins Neuraptive Therapeutics, Inc. as Chairman and CEO. (Photo: Business Wire)

    "We are very pleased to have attracted an experienced and accomplished industry executive to lead Neuraptive," said Ivan Gergel, MD, a partner at New Rhein Healthcare Investors and a member of Neuraptive's Board of Directors. "Having led numerous companies from their development stage through acquisition or commercialization, Bob brings deep knowledge from the pharmaceutical and biotech industries, with significant executive, development, commercial, and deal-making capabilities."

    Mr. Radie brings more than three decades of industry experience, working in both public and private pharmaceutical and biotech companies, and across a range of therapeutic areas. He has held senior executive positions in six companies, including serving as Chief Executive Officer of Zyla Life Sciences, Inc. Transmolecular Inc, and Topaz Pharmaceuticals, Inc., which was acquired by Sanofi Pasteur. Mr. Radie also served as Chief Business Officer at Prestwick Pharmaceuticals, Inc., which was sold to Biovail Pharmaceutics, Morphotek, Inc., which was sold to Eisai Co., Ltd., and Senior Vice President of Strategy and Planning at Vicuron Pharmaceuticals, Inc., which was sold to Pfizer.

    Mr. Radie currently serves on the board of directors of several companies, including Paratek Pharmaceuticals, Inc. (NASDAQ:PRTK), and Rockwell Medical Technologies Inc. (NASDAQ:RMTI). He also serves as a member of the board of directors of Life Sciences Pennsylvania (LSPA), the Pennsylvania industry advocacy group.

    "I am eager to get started with Neuraptive as the company transitions into a clinical-stage organization on the verge of enrolling the first patients in an important Phase 2 trial and having recently received Fast Track designation from the FDA," said Bob Radie. "I look forward to working with the board of directors and the experienced team of executives and employees to bring potentially game-changing technologies to patients who have experienced nerve injuries and to the surgeons who treat them."

    The following changes are being made to the board of directors as the company progresses to a clinical-stage organization. Gino DiSciullo, Ph.D., a co-founder of Neuraptive, has stepped down as a director. "We want to thank Gino for his contributions to the company over the last two years," said Ivan Gergel. In the coming months, an additional independent director will be added.

    In addition, the New Rhein Investors collectively have indicated their intention to invest at least $3,000,000 in the next Qualified Financing, provided that the terms and conditions of such financing are acceptable to the New Rhein Investors, New Rhein previously invested $7.5M in the company's Series A Financing.

    About Neuraptive Therapeutics

    Neuraptive is creating innovative novel therapies for nerve repairs to improve clinical outcomes for patients and surgeons who care for them. The company's franchise therapeutic product, NTX-001, has the potential to improve the quality and speed of recovery of nerve sensation and function for eligible patients who have sustained traumatic injuries or who are undergoing reconstructive surgical procedures. Neuraptive is rapidly advancing its pipeline and will leverage its capabilities to transition into a clinical-stage company. Investors include New Rhein Healthcare Investors through its Fund 18 and Ben Franklin Technology Partners. The company is headquartered in Philadelphia, PA, and has offices near Boulder, CO, as well as surgical translational medical facilities at the Colorado University Anschutz Medical Center in Aurora, CO. For more information, see www.neuraptive.com.

    About New Rhein Healthcare Investors

    New Rhein is a venture capital/early growth stage fund manager whose investment strategy focuses on proven molecules used in new ways, such as new delivery forms and potential new uses and indications. In this way, New Rhein limits science-based risk and concentrates on development and execution. Prior investments have included medicines for Alzheimer's disease, ophthalmic disorders, respiratory disease, and molecular oncology diagnostics. New Rhein's partners, associates, and advisors are knowledgeable former industry executives with solid track records of operational, investment, and transactional experience. New Rhein combines significant deal-making expertise with deep operating experience, allowing it to tailor the right deal for the right situation and work with its portfolio companies to achieve maximum value for their products. For more information, see www.newrhein.com.

    Cautionary Note on Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. including, among others, statements we make regarding the time for the commencement of clinical trials. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control.

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  17. WIXOM, Mich., June 10, 2020 (GLOBE NEWSWIRE) -- 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 appointment of industry leader and renowned authority on kidney disease, Allen R. Nissenson, M.D., F.A.C.P., to its Board of Directors, effective June 11, 2020. Dr. Nissenson serves as an Emeritus Professor of Medicine at the David Geffen School of Medicine at University California Los Angeles, Emeritus Chief Medical Officer of DaVita Kidney Care, and a member of the Board of Directors of Angion Biomedica Corp.

    "We are pleased to welcome Allen to the Board of Directors," said…

    WIXOM, Mich., June 10, 2020 (GLOBE NEWSWIRE) -- 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 appointment of industry leader and renowned authority on kidney disease, Allen R. Nissenson, M.D., F.A.C.P., to its Board of Directors, effective June 11, 2020. Dr. Nissenson serves as an Emeritus Professor of Medicine at the David Geffen School of Medicine at University California Los Angeles, Emeritus Chief Medical Officer of DaVita Kidney Care, and a member of the Board of Directors of Angion Biomedica Corp.

    "We are pleased to welcome Allen to the Board of Directors," said John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical. "We expect Allen's clinical, regulatory and public policy expertise, combined with his senior executive experience at a large dialysis organization, will make him a valuable advisor as we seek to expand the reach and impact of Triferic® (ferric pyrophosphate citrate) in End-Stage Renal Disease."

    "I am delighted to join Rockwell Medical's Board of Directors at this exciting time for the Company," said Dr. Nissenson. "I look forward to working with the Board and Executive Team to help transform the treatment of kidney patients and create value for patients and shareholders."

    In addition to his current roles, Dr. Nissenson is the immediate past Chair of Kidney Care Partners, immediate past Co-Chair of the Kidney Care Quality Alliance, and he served as Director of the Dialysis Program and Associate Dean at the David Geffen School of Medicine. He is a former President of the Renal Physicians Association and current member of the Government Affairs Committee. Dr. Nissenson also previously served as President of the Southern California End-Stage Renal Disease Network, as well as Chair of the Medical Review Board. He earned his M.D. from Northwestern University Medical School.

    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 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 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%).

    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

    Media:

    David Rosen

    Argot Partners

    212.600.1902

    Primary Logo

    View Full Article Hide Full Article
  18. WIXOM, Mich., May 26, 2020 (GLOBE NEWSWIRE) -- 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 filing of a New Drug Submission ("NDS") with Health Canada for Triferic AVNU (ferric pyrophosphate citrate). The Company seeks an indication to promote Triferic AVNU in Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The filing is the first international regulatory submission for the intravenous therapy.

    "Our submission to Health Canada reflects an important milestone for our Company as well as for…

    WIXOM, Mich., May 26, 2020 (GLOBE NEWSWIRE) -- 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 filing of a New Drug Submission ("NDS") with Health Canada for Triferic AVNU (ferric pyrophosphate citrate). The Company seeks an indication to promote Triferic AVNU in Canada for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease. The filing is the first international regulatory submission for the intravenous therapy.

    "Our submission to Health Canada reflects an important milestone for our Company as well as for the more than 20,000 Canadians undergoing hemodialysis," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "Rockwell Medical is focused on transforming the treatment of iron deficiency and anemia around the world to improve outcomes for patients. If approved by Health Canada, we expect Triferic AVNU to be an important new treatment option for dialysis clinics and the patients they serve."

    Rockwell Medical has a distribution agreement with RMC Canada, through which Rockwell Medical will receive a transfer price based on Triferic sales in Canada, subject to Canadian regulatory approval.

    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 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 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 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: 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; 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; 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

    Media:
    David Rosen
    Argot Partners
    212.600.1902
     

    Primary Logo

    View Full Article Hide Full Article
  19. -Q1 2020 revenue of $15.9 million-

    -Received FDA Approval of Triferic® AVNUTM-

    -Significant expansion of Triferic (ferric pyrophosphate citrate) Dialysate Evaluation Programs during Q1 2020-

    -Retrospective real-world analysis over 18 months shows reduction in ESA and traditional IV iron use, stable-to-increasing hemoglobin levels, reductions in missed treatments, and quality-of-life improvements following clinical adoption of Triferic-

    -Strengthened financial position with $48.9 million in cash, cash equivalents and marketable securities as of March 31, 2020-

    -Conference call and webcast scheduled for today at 4:30 p.m. ET-

    WIXOM, Mich., May 11, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company…

    -Q1 2020 revenue of $15.9 million-

    -Received FDA Approval of Triferic® AVNUTM-

    -Significant expansion of Triferic (ferric pyrophosphate citrate) Dialysate Evaluation Programs during Q1 2020-

    -Retrospective real-world analysis over 18 months shows reduction in ESA and traditional IV iron use, stable-to-increasing hemoglobin levels, reductions in missed treatments, and quality-of-life improvements following clinical adoption of Triferic-

    -Strengthened financial position with $48.9 million in cash, cash equivalents and marketable securities as of March 31, 2020-

    -Conference call and webcast scheduled for today at 4:30 p.m. ET-

    WIXOM, Mich., May 11, 2020 (GLOBE NEWSWIRE) -- 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 reported financial results and a business update for quarter ended March 31, 2020.

    "In my new role, my charge is to maximize the commercial potential of our two FDA-approved products, Triferic Dialysate and Triferic AVNU, while developing Rockwell Medical into a more medically- and scientifically-driven company, which includes leading the strategic identification and pursuit of new therapeutic areas for our ferric pyrophosphate citrate platform," said Russell Ellison, M.D., M.Sc., President and Chief Executive Officer of Rockwell Medical. "I am pleased to report continued progress in our commercialization of Triferic Dialysate in the first quarter, including an acceleration of Triferic Dialysate Evaluation Programs and a continued increase in contracted clinics. Importantly, we secured FDA approval of Triferic AVNU at the end of March and are working diligently to prepare for a successful launch of this intravenous ("IV") formulation later this year."

    Dr. Ellison added: "In addition, we are encouraged by the top-line data announced today from a retrospective real-world analysis of Triferic Dialysate within a dialysis clinic. Following adoption of Triferic within the studied clinic, we observed the reduction of the use of erythropoietin stimulating agents ("ESAs") and traditional IV iron, improvement in hemoglobin levels, fewer missed appointments among patients, and an improvement in patients' quality of life. These measures are important factors in patient care and speak to the value that Triferic can confer to providers, patients and the overall healthcare system."

    First Quarter 2020 Operational Highlights

    Triferic Dialysate

    • The Company currently has active or committed Evaluation Programs with independent dialysis clinics and small dialysis chains representing more than 2,250 patients and 36 clinics, a 260% increase from December 31, 2019.
       
    • Signed contracts with four additional clinics during the first quarter of 2020, and an additional eight clinics that are affiliated with MDO were trained and approved for adoption as of March 31, 2020.
       
    • Nearly 2,000 contracted patients on therapy as of March 31, 2020, representing over 300,000 annualized treatments.
       
    • Triferic net sales were $0.3 million in the first quarter of 2020.
       
    • Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic Dialysate in India. Rockwell Medical received an upfront fee and will be eligible for milestone payments and royalties on net sales.
       
    • With respect to the COVID-19 pandemic, the Company has implemented precautions to reduce the risk of possible exposure by restricting employee travel, adopting new preventative safety measures within our manufacturing facilities, instituting a work-from-home policy for substantially all employees, excluding our essential manufacturing and distribution employees, and leveraging virtual technology for the sales force to use in its communications with customers. The Company has experienced no material impact on its supply chain to date, and has experienced a small increase in demand for its dialysis concentrates products, believed to be attributed to customers building safety stock and turning to Rockwell Medical in instances where other suppliers have not been able to meet demand.

    Triferic AVNU (IV Formulation)

    • On March 27, 2020, Rockwell Medical announced that the FDA approved its New Drug Application for Triferic AVNU, its intravenous formulation of Triferic.

    • With this approval, Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

    • The Company has initiated a commercial strategy to leverage the experience gained from the 2019 launch of Triferic Dialysate and lay the groundwork for the commercial introduction of Triferic AVNU. The Company expects to launch evaluation programs during the third quarter of 2020 to allow clinics to gain direct experience with Triferic AVNU, and expects Triferic AVNU to be available commercially during the fourth quarter of 2020, following the completion of the initial evaluation programs.

    Triferic Real-World Data

    Today, the Company announced the top-line results from a retrospective analysis of Triferic Dialysate clinical use. The analysis included patient outcomes from an independent dialysis clinic with approximately 65 patients, from a baseline period of 3 months prior to the adoption of Triferic Dialysate through 18 months post-adoption.

    "Today's results, while a snapshot from a single clinic, demonstrate meaningful clinical and real-world trends observed following the adoption of Triferic Dialysate," said Marc Hoffman, M.D., Chief Medical Officer of Rockwell Medical. "The potential clinical and financial implications from this analysis are compelling and we believe they support Triferic's important place in the physician's arsenal for treating adult patients with hemodialysis-dependent chronic kidney disease."

    Findings from the analysis include:

    • A more than 23% reduction in ESAs utilized per patient, per week during the sixth quarter after Triferic Dialysate administration vs. baseline.

    • A 74% reduction in traditional IV iron (ferric gluconate) utilization per patient, per week, beginning at month 3 and continuing through the observation period vs. baseline.

    • Stable to increasing hemoglobin levels, with consistent hemoglobin control throughout the observation period.

    • A meaningful reduction in missed treatments of nearly one-fifth and one-half for the 5th and 6th quarters, respectively.

    • Improvements in key quality of life indicators as measured by KDQOLTM-36.

    The Company is evaluating potential publication and/or presentation of the full results of the findings at a future medical meeting.

    First Quarter 2020 Corporate Updates

    • The Company announced the appointment of Russell H. Ellison, M.D., M.Sc., as President and Chief Executive Officer, effective April 20, 2020. Dr. Ellison, who will continue to serve as a member of the Board of Directors for Rockwell Medical, brings broad medical, clinical development and leadership experience to the role.
       
    • The Company announced the appointment of Robert S. Radie to its Board of Directors, effective March 31, 2020. Mr. Radie brings more than three decades of industry experience, working in senior executive roles with both public and private pharmaceutical and biotech companies across a range of therapeutic areas.
       
    • On March 17, 2020, the Company 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. The first $22.5 million tranche was funded on March 16, 2020. The Company will be eligible to draw on a second tranche of $5.0 million following the completion of certain milestones, which includes the FDA approval of Triferic AVNU, and a third tranche of $7.5 million upon the achievement of certain additional milestones, including the achievement of certain Triferic sales thresholds.
       
    • The Company completed the pricing of an underwritten public offering of the Company's common stock in February 2020 for gross proceeds of approximately $8.1 million, before deducting issuance costs.

    First Quarter 2020 Financial Results

    Net sales for the first quarter of 2020 were $15.9 million, an increase of 2% compared to net sales of $15.6 million for the first quarter of 2019. The increase was primarily due to an increase in U.S. product sales of Triferic Dialysate as a result of the commercial launch in May 2019.

    Cost of sales for the first quarter of 2020 was $14.7 million, resulting in gross profit of $1.1 million, compared to cost of sales of $14.5 million and a gross profit of $1.0 million during the first quarter of 2019. Gross profit increased by $0.1 million in the first quarter of 2020 compared to the first quarter of 2019 due primarily to an increase in U.S. product sales of Triferic Dialysate as a result of the commercial launch in May 2019, partially offset by a decrease in gross profit for our dialysis concentrate products.

    Selling and marketing expenses were $2.1 million for the first quarter of 2020 compared to $3.1 million for the first quarter of 2019. The decrease was due primarily to various marketing investments made during the first quarter of 2019 to support the commercial launch of Triferic Dialysate that did not recur in the first quarter of 2020, partially offset by investments in selling and marketing headcount to support the ongoing launch of Triferic Dialysate and the upcoming launch of Triferic AVNU.

    General and administrative expenses were $5.3 million for the first quarter of 2020 compared to $6.2 million for the first quarter of 2019. The decrease was primarily due to a reduction in legal expenses, stock-based compensation and consulting costs, partially offset by an increase in headcount and insurance expenses.

    Research and product development expenses were $1.8 million for the first quarter of 2020 compared to $0.5 million for the first quarter of 2019. The increase was due primarily to investments the Company is making in its medical platform to support the development and the global launch of Triferic, including medical, scientific and technical staffing costs, clinical trial costs and consulting expenses. We expect our research and product development expenses to increase in the future due to additional clinical development of our ferric pyrophosphate citrate technology platform, innovations in administration of Triferic, the continuation of the pediatric clinical trial for Triferic, and an increase in headcount to support medical education efforts for Triferic.

    Net loss for the first quarter of 2020 was $8.0 million, or $0.12 per basic and diluted share, compared to a net loss for first quarter of 2019 of $8.7 million, or $0.15 per basic and diluted share.

    Cash, cash equivalents, and investments available-for-sale totaled $48.9 million as of March 31, 2020, compared to approximately $26.0 million on December 31, 2019. Cash used in operating activities was $6.5 million during the first quarter of 2020. The balance sheet was strengthened by a $35 million debt financing agreement with Innovatus, announced in March 2020, from which the Company drew $22.5 million at closing, as well as the underwritten public offering of the Company's common stock in February 2020 for gross proceeds of approximately $8.1 million, before deducting issuance costs. Additionally, the Company has approximately $35 million remaining for issuance under its at-the-market equity offering facility, pursuant to which the Company may sell, at such times and amounts as it deems appropriate, shares of common stock to support its business plan, subject to certain restrictions on use.

    First Quarter 2020 and Business Update Conference Call and Webcast

    Rockwell Medical's management team will host a conference call and audio webcast today at 4:30 p.m. ET to discuss Q1 2020 financial results and provide a business update.

    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 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 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 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: statements about the challenges inherent in new product development and other indications and therapeutics areas for our products; the success of our commercialization strategy; the success and timing of our commercialization of Triferic Dialysate, which was launched in May 2019; the  success and timing of our evaluation program for Triferic AVNU and for a commercial launch of Triferic AVNU in the United States; 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; 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; the timing and availability of future publications and presentations; potential future milestone payments and royalties under our 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.  All other product names, logos, and brands are property of their respective owners in the United States and/or other countries. All company, product and service names used on this website are for identification purposes only. Use of these names, logos, and brands does not imply endorsement.

    Financial Tables Follow

    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Balance Sheets
    (unaudited)

      March 31,   December 31, 
      2020   2019
               
    ASSETS          
    Cash and Cash Equivalents $ 37,399,801     $ 11,794,526  
    Investments Available-for -Sale   11,456,285       14,250,176  
    Accounts Receivable, net   4,586,748       4,202,725  
    Inventory   4,292,768       3,646,906  
    Prepaid and Other Current Assets   1,758,002       2,979,504  
    Total Current Assets   59,493,604       36,873,837  
    Property and Equipment, net   2,430,113       2,433,405  
    Inventory, Non-Current   623,000       441,000  
    Right of Use Assets, net   2,797,759       3,212,530  
    Goodwill   920,745       920,745  
    Other Non-current Assets   560,588       434,935  
    Total Assets $ 66,825,809     $ 44,316,452  
    LIABILITIES AND STOCKHOLDERS' EQUITY          
    Accounts Payable $ 3,123,181     $ 3,018,424  
    Accrued Liabilities   6,160,047       4,517,732  
    Settlement Payable   57,000       104,000  
    Lease Liability - Current   1,351,348       1,493,394  
    Deferred License Revenue - Current   2,179,383       2,233,640  
    Insurance Financing Note Payable   190,855       763,422  
    Customer Deposits   146,831       55,100  
    Other Current Liability - Related Party   148,523       187,849  
    Total Current Liabilities   13,357,168       12,373,561  
               
    Lease Liability - Long-Term   1,559,749       1,780,626  
    Term Loan, Net of Issuance Costs   20,683,704        
    Deferred License Revenue - Long-Term   9,450,983       9,842,762  
    Total Liabilities   45,051,604       23,996,949  
               
    Stockholders' Equity:          
    Preferred Stock, $0.0001 par value, no shares issued and outstanding at March 31, 2020 and December 31, 2019          
    Common Stock, $0.0001 par value; 170,000,000 shares authorized; 69,049,102 and 65,378,890 shares issued and outstanding at March 31, 2020 and December 31, 2019, respectively   6,905       6,538  
    Additional paid-in capital   336,216,422       326,777,250  
    Accumulated Deficit   (314,500,003 )     (306,516,265 )
    Accumulated Other Comprehensive Income   50,881       51,980  
    Total Stockholders' Equity   21,774,205       20,319,503  
    Total Liabilities And Stockholders' Equity $ 66,825,809     $ 44,316,452  
               


    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    Condensed Consolidated Statements of Operations
    (unaudited)

      Three Months Ended March 31, 2020   Three Months Ended March 31, 2019
               
    Net Sales $ 15,856,539     $ 15,559,439  
    Cost of Sales   14,743,613       14,549,047  
    Gross Profit   1,112,926       1,010,392  
    Selling and Marketing   2,072,798       3,102,378  
    General and Administrative   5,273,433       6,220,499  
    Research and Product Development   1,821,488       497,276  
    Operating Loss   (8,054,793 )     (8,809,761 )
               
    Other Income (Expense)          
    Realized Gain on Investments   1,929       13,888  
    Interest Expense   (101,951 )      
    Interest Income   171,077       117,526  
    Total Other Income   71,055       131,414  
               
    Net Loss $ (7,983,738 )   $ (8,678,347 )
               
               
    Basic and Diluted Net Loss per Share $ (0.12 )   $ (0.15 )
               
    Basic and Diluted Weighted Average Shares Outstanding   67,518,240       57,098,947  
               

     

    CONTACTS

    Investors:
    Argot Partners
    212.600.1902

    Media:
    David Rosen
    Argot Partners
    212.600.1902

     

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  20. WIXOM, Mich., April 20, 2020 (GLOBE NEWSWIRE) -- 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…

    WIXOM, Mich., April 20, 2020 (GLOBE NEWSWIRE) -- 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 Partners
    212.600.1902

    Media:
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    Argot Partners
    212.600.1902

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  21. – Enhances Triferic platform by providing patients with greater access to Rockwell Medical's innovative therapeutic by expanding administration options for clinicians –

    – Major milestone supports the potential for expanding global adoption of Triferic and transforming the standard of care for anemia management in hemodialysis patients –

    WIXOM, Mich., March 27, 2020 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for its intravenous formulation of Triferic, Triferic…

    – Enhances Triferic platform by providing patients with greater access to Rockwell Medical's innovative therapeutic by expanding administration options for clinicians –

    – Major milestone supports the potential for expanding global adoption of Triferic and transforming the standard of care for anemia management in hemodialysis patients –

    WIXOM, Mich., March 27, 2020 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration ("FDA") has approved its New Drug Application ("NDA") for its intravenous formulation of Triferic, Triferic AVNU. With this approval, Triferic AVNU joins Triferic Dialysate as the only FDA-approved products indicated to replace iron and maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease.

    Triferic is a novel, physiologic iron maintenance therapy that provides bioavailable iron to replace iron lost during every dialysis treatment and maintain hemoglobin. While Triferic Dialysate is designed to be administered via liquid bicarbonate, Triferic AVNU is designed for direct intravenous infusion, which provides hemodialysis patients with greater access to the Triferic platform and expands administration options for clinicians. Triferic AVNU can be administered regardless of a dialysis center's mode of bicarbonate delivery. Many dialysis centers in international markets and an increasing number of dialysis centers in the U.S. have converted to the use of dry bicarbonate cartridges or bags and on-line dialysate generation, which is not compatible with Triferic Dialysate.

    "The approval of Triferic AVNU is a major milestone as we further progress toward our goal of transforming anemia management across the globe. With Triferic AVNU, more adult hemodialysis patients in the U.S will have access to the benefits of this unique therapeutic, regardless of the way their clinic generates bicarbonate. Clinicians will now have the added flexibility to administer Triferic intravenously to a broader group of patients who can benefit from physiologic iron maintenance therapy to manage their anemia," stated Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    "Clinical trials have demonstrated that patients treated with Triferic receive steady and consistent bioavailable iron to replace the iron that is lost at every dialysis treatment and hemoglobin is maintained. Now, even in clinics where delivering Triferic through the dialysate is not operationally possible, Triferic AVNU is an option. This may be especially important for patients who are difficult to manage, or for other special patient populations," added Dr. Steven Fishbane, Chief of Nephrology of Northwell Health and Professor of Medicine at the Zucker School of Medicine.

    Over the next several months, the Company plans to initiate a commercial strategy that leverages the experience gained from the 2019 launch of Triferic Dialysate and lays the groundwork for the commercial introduction of Triferic AVNU. The Company expects to launch Evaluation Programs during the third quarter of 2020 to allow clinics to gain direct experience with Triferic AVNU, and the Company expects Triferic AVNU to be available commercially following the completion of the initial Evaluation Programs.

    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 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 between 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 timing, as well as commercialization opportunity and 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.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E:  

    Source: Rockwell Medical, Inc.

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  22. WIXOM, Mich., March 20, 2020 (GLOBE NEWSWIRE) -- 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 reiterated that Medical Resource Acquisition Group LLC (MRAG) failed to properly deliver a notice of director nominations under the Company's Bylaws within the prescribed advance notice period.

    While MRAG has continued its attempts to confuse shareholders into believing otherwise, the Company has been abundantly clear in its communications with MRAG and its advisors that MRAG's three director nominees will not stand for election at the Company's 2020 annual meeting of stockholders. The Company…

    WIXOM, Mich., March 20, 2020 (GLOBE NEWSWIRE) -- 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 reiterated that Medical Resource Acquisition Group LLC (MRAG) failed to properly deliver a notice of director nominations under the Company's Bylaws within the prescribed advance notice period.

    While MRAG has continued its attempts to confuse shareholders into believing otherwise, the Company has been abundantly clear in its communications with MRAG and its advisors that MRAG's three director nominees will not stand for election at the Company's 2020 annual meeting of stockholders. The Company will also make copies of such correspondence available on our website, https://ir.rockwellmed.com/. The Company continues to advise shareholders to exercise caution in connection with this matter.

    Gibson, Dunn & Crutcher LLP is acting as legal counsel to Rockwell Medical.

    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.

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    Forward-Looking Statements

    This press release may contain statements which may be considered forward-looking within the meaning of the U.S. federal securities laws. These statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ materially from results expressed or implied in this press release. Additional information is contained in the Risk Factors sections of Rockwell's most recent reports filed with the SEC on Form 10-K and Form 10-Q. Rockwell does not intend to update these forward-looking statements as a result of future events or developments.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  23. WIXOM, Mich., March 17, 2020 (GLOBE NEWSWIRE) -- 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…

    WIXOM, Mich., March 17, 2020 (GLOBE NEWSWIRE) -- 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:

    Source: Rockwell Medical, Inc.

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  24. – Company reports positive adoption trends for Dialysate Triferic® (ferric pyrophosphate citrate), highlighted by 77% increase in clinics under contract –

    -- Signed contract with a Medium-Sized Dialysis Organization (MDO) for the purchase of Dialysate Triferic; provides access to up to 160 clinics --

    -- Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic in India –

    WIXOM, Mich., March 12, 2020 (GLOBE NEWSWIRE) -- 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 reported business highlights and financial results for the three months…

    – Company reports positive adoption trends for Dialysate Triferic® (ferric pyrophosphate citrate), highlighted by 77% increase in clinics under contract –

    -- Signed contract with a Medium-Sized Dialysis Organization (MDO) for the purchase of Dialysate Triferic; provides access to up to 160 clinics --

    -- Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic in India –

    WIXOM, Mich., March 12, 2020 (GLOBE NEWSWIRE) -- 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 reported business highlights and financial results for the three months and full year ended December 31, 2019.

    "We are pleased with the steady progress we are making to drive adoption of Dialysate Triferic as we strive to establish Triferic as the standard of care for hemodialysis patients in the United States. After two full quarters in market post-launch, our three-month Evaluation Program for Dialysate Triferic, with a consistent 75% conversion rate, continues to be a success and represents validation for the clinical benefits that dialysis centers see when they initiate Triferic therapy. In addition, with our first signed contract with an MDO, and continued execution of our sales, marketing and medical education initiatives, we expect adoption rates to accelerate through 2020. In support of the Triferic platform, we continue to invest in building our medical capabilities and our real-world data program in an effort to educate the clinical community about the unique properties of our highly innovative therapy," stated Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    Recent Business and Financial Highlights:

    • Key highlights for the Dialysate Triferic U.S. market introduction include:
       
      • Entered into a contract with a Medium-Size Dialysis Organization (MDO) for the purchase of Dialysate Triferic. Provides access to up to 160 clinics for Dialysate Triferic, representing more than 10,000 patients. Successfully initiated Dialysate Triferic administration and purchasing in top five KOL-led clinics within system.
      • Signed contracts with 10 additional clinics during the fourth quarter of 2019, an increase of 77% compared to the number of clinics contracted at September 30, 2019.
      • Contracted patients on therapy increased to 1,650 as of December 31, 2019, representing an increase of 100,0000 annualized treatments.
      • 75% of clinics that completed an Evaluation Program during the fourth quarter have converted to contracted customers and more than 80% of customers continue to order Dialysate Triferic on an ongoing basis.
    • Strengthened medical capabilities with the appointments of Marc Hoffman, MD as Chief Medical Officer; Russell Ellison, MD, to the Board of Directors; and three world-renowned nephrologists to Medical Advisory Board: Stephen Fishbane, MD; Jay Wish, MD; and Anatole Besarab, MD.
    • Entered into exclusive license and supply agreements with Sun Pharma for the rights to commercialize Triferic in India. Rockwell Medical will receive an upfront fee and will be eligible for milestone payments and royalties on net sales.
    • The Company has a PDUFA date of March 28, 2020 for I.V. Triferic, which was developed pursuant to a Special Protocol Assessment (SPA) with the FDA. If approved, I.V. Triferic would allow dialysis centers to administer Triferic to patients regardless of the mode of bicarbonate delivery being used.
    • Sales were $15.5 million and $61.3 million for the three and twelve months ended December 31, 2019, respectively, including sales of Triferic of approximately $0.2 million and $0.5 million, respectively.
    • The Company completed the pricing of an underwritten public offering of the Company's common stock in February 2020 for gross proceeds of approximately $8.1 million, before deducting underwriting discounts; and
    • Cash flow used in operations for the three months ended December 31, 2019 was $5.3 million. As of December 31, 2019, the Company had approximately $26.0 million of cash, cash equivalents and investments available-for-sale. Additionally, the Company has approximately $35 million remaining under its at-the-market equity offering facility, pursuant to which the Company may sell, at such times and amounts as it deems appropriate, shares of common stock to support its business plan, subject to certain restrictions on use.

    "2019 was a pivotal year for Rockwell Medical. With the commercial launch of Dialysate Triferic, and the NDA submission for the I.V. formulation, we achieved important milestones and established a strong foundation for future growth and expansion. We are very pleased that we are gaining traction in bringing this much-needed therapeutic to hemodialysis patients both in the U.S. and around the world.  Our experience thus far informs our belief that Triferic has the potential to improve the way anemia is managed in a variety of disease states, and we are actively focused on identifying and prioritizing other therapeutic indications for future development," concluded Mr. Paul.

    Fourth Quarter 2019 Financial Results

    Net loss for the fourth quarter of 2019 was $7.3 million, or ($0.11) per basic and diluted share, compared to a net loss of $9.4 million, or ($0.17) per basic and diluted share, in the fourth quarter of 2018. The decrease in net loss for the fourth quarter of 2019 compared to the fourth quarter of 2018 primarily reflects a reduction in general and administrative expenses and research and development expenses for licenses acquired, partially offset by an increase in research and development expenses to support the Company's investments in its medical platform.

    Net sales for the fourth quarter of 2019 were $15.5 million compared to sales of $16.9 million for the fourth quarter of 2018. Net sales of hemodialysis concentrates to dialysis providers and distributors in the U.S. and abroad were $15.3 million for the three months ended December 31, 2019 compared to $16.8 million for the three months ended December 31, 2018. The decrease in net sales was due to a decrease in international concentrates sales of $1.1 million, a decrease of $0.7 million in concentrates sales to Baxter related to true-ups for cost of sales and transportation cost pass-throughs, partially offset by increased sales to DaVita, Inc. of $0.3 million and Triferic sales of $0.2 million. 

    Cost of sales during the fourth quarter of 2019 was $14.4 million compared to cost of sales of $15.7 million during the fourth quarter of 2018. The decrease was due primarily to a decrease in distribution costs due to reduced rates for third party shipping and reduced costs for materials and overhead tied to the reduction in concentrates sales volume. 

    Gross profit for the fourth quarter of 2019 was approximately $1.1 million compared to gross profit of $1.2 million for the fourth quarter of 2018. The decrease in gross profit was primarily due to a reduction in concentrates sales compared to the fourth quarter of 2018, partially offset by an increase in Triferic sales.

    Selling and marketing expenses were $1.9 million during the three months ended December 31, 2019 compared with $0.3 million during the three months ended December 31, 2018.  The increase of $1.6 million was due to investments the Company has made to develop a commercial platform to support the launch of Triferic.

    General and administrative expenses were $4.7 million during the three months ended December 31, 2019 compared with $7.6 million during the three months ended December 31, 2018. The decrease of $2.9 million was primarily driven by reductions in compensation, legal, consulting, and recruiting expenses, partially offset by an increase in insurance and facility-related expenses.

    Research and product development expenses were $2.0 million for the three months ended December 31, 2019 compared with $1.6 million during the three months ended December 31, 2018. The increase was due primarily to an increase in clinical trial and consulting expenses, partially offset by a reduction due to the write off of Calcitriol inventory that occurred in the fourth quarter of 2018. The Company expects its research and product development expenses to increase in the future due to additional clinical development of Dialysate and I.V. Triferic, including the pediatric clinical trial for Triferic, expenses associated with real-world data collection and analysis for Triferic, an increase in headcount to support medical education efforts for Triferic and potential investments in developing Triferic for new clinical indications. 

    Research and development for licenses acquired from a related party were nil for the three months ended December 31, 2019 compared to $1.1 million for the three months ended December 31, 2018.

    Other income for the three months ended December 31, 2019 was $0.1 million, consisting primarily of interest income. Other income for the three months ended December 31, 2018 was approximately $49,000, consisting primarily of interest income.

    Full Year 2019

    For the year ended December 31, 2019, net sales were $61.3 million compared to $63.4 million for the year ended December 31, 2018. The decrease was primarily due to lower international concentrates sales compared to the year ended December 31, 2018, partially offset by an increase in Triferic net sales and sales of concentrates pursuant to the Company's contract with DaVita Inc.

    Cost of sales for the year ended December 31, 2019 was $58.5 million, resulting in a gross profit of $2.8 million in 2019, compared to cost of sales of $65.0 million and a gross loss of $1.6 million in 2018. Gross profit increased in 2019 compared to 2018, due primarily to non-cash charges taken for inventory reserves for Triferic during the year ended December 31, 2018, partially offset by a gross profit decrease in dialysis concentrates products during 2019.

    Selling and marketing expenses were $9.1 million during the year ended December 31, 2019 compared with $1.0 million during the year ended December 31, 2018. The increase of $8.1 million was due to investments the Company is making in developing a commercial platform to support the launch of Triferic.

    General and administrative expenses were $21.0 million for the year ended December 31, 2019 compared to $22.1 million for the year ended December 31, 2018. The decrease was primarily driven by a reduction in legal and related costs associated with various matters, including litigation activities, related to the departure of certain executives and directors during 2018, partially offset by an increase in insurance, stock-based compensation and facility-related expenses.

    Settlement expenses were $0.4 million for the year ended December 31, 2019 compared to $1.0 million for the year ended December 31, 2018.

    Research and product development expenses were $6.9 million for the year ended December 31, 2019 compared to $5.6 million for the year ended December 31, 2018. The increase was due to the Company's commitment to investing in and building its medical capabilities, including generating data from studies and real-world use of Triferic to support medical education and development efforts for Triferic, as well as the expansion of the Company's internal medical affairs staff.

    Research and development for licenses acquired from a related party were nil for the year ended December 31, 2019 compared to $1.1 million for the year ended December 31, 2018.

    Net loss for the year ended December 31, 2019 was $34.1 million, or ($0.56) per basic and diluted share, compared to a net loss of $32.1 million, or ($0.61) per basic and diluted share, in 2018.

    The Company encourages shareholders to also review its Form 10-K for the year ended December 31, 2019, as filed by the Company with the United States Securities and Exchange Commission ("SEC").

    Conference Call

    As previously announced, Rockwell Medical management will host its fourth quarter 2019 conference call as follows:

    Date: Thursday, March 12, 2020
    Time: 4:30 PM ET
    Telephone U.S: (877) 383-7438
      International: (678) 894-3975
    Webcast (live and archive): https://edge.media-server.com/mmc/p/jmkgdrca

    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, 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; the timing and regulatory approval process for our NDA filing for I.V. Triferic as filed with the FDA: the potential market opportunity for I.V. Triferic, 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 Dialysate Triferic, 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, health, 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: 212-452-2793
    E:

    Source: Rockwell Medical, Inc.

    Financial Tables Follow


    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES 
    Condensed Consolidated Balance Sheets
    (unaudited)

                 
                 
        December 31,    December 31, 
        2019
      2018
                 
    ASSETS            
    Cash and Cash Equivalents   $ 11,794,526     $ 22,713,980  
    Investments Available-for -Sale     14,250,176       10,818,059  
    Accounts Receivable, net of a reserve of $8,932 in 2019 and $2,104 in 2018     4,202,725       6,979,514  
    Insurance Receivable           371,217  
    Inventory     3,646,906       4,038,778  
    Prepaid and Other Current Assets     2,979,504       1,903,682  
    Total Current Assets     36,873,837       46,825,230  
    Property and Equipment, net     2,433,405       2,638,293  
    Inventory, Non-Current     441,000       1,637,000  
    Right of Use Assets, net     3,212,530        
    Goodwill     920,745       920,745  
    Other Non-current Assets     434,935       536,516  
    Total Assets   $ 44,316,452     $ 52,557,784  
    LIABILITIES AND STOCKHOLDERS' EQUITY            
    Accounts Payable   $ 3,018,424     $ 4,492,071  
    Accrued Liabilities     4,517,732       5,129,761  
    Settlement Payable     104,000       416,668  
    Lease Liability - Current     1,493,394        
    Deferred License Revenue     2,233,640       2,252,868  
    Insurance Financing Note Payable     763,422        
    Customer Deposits     55,100       63,143  
    Other Current Liability - Related Party     187,849       850,000  
    Total Current Liabilities     12,373,561       13,204,511  
                 
    Lease Liability - Long Term     1,780,626        
    Deferred License Revenue     9,842,762       12,076,399  
    Total Liabilities     23,996,949       25,280,910  
                 
    Stockholders' Equity:            
    Preferred Shares, $0.0001 par value, 2,000,000 shares authorized, no shares issued and outstanding at December 31, 2019 and 2018            
    Common Stock, $0.0001 par value, 65,378,890 and 57,034,154 shares issued and outstanding at December 31,2019 and 2018, respectively     6,538       5,703  
    Additional Paid-in Capital     326,777,250       299,596,257  
    Accumulated Deficit     (306,516,265 )     (272,388,234 )
    Accumulated Other Comprehensive Income     51,980       63,148  
    Total Stockholders' Equity     20,319,503       27,276,874  
    Total Liabilities And Stockholders' Equity   $ 44,316,452     $ 52,557,784  
                     

    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES 
    Condensed Consolidated Statements of Operations 
    (unaudited)

         
         
        Three Months Ended
    December 31, 2019
      Three Months Ended
    December 31, 2018
      Year Ended
    December 31, 2019
      Year Ended
    December 31, 2018
                             
    Net Sales   $ 15,490,325     $ 16,854,259     $ 61,302,801     $ 63,388,617  
    Cost of Sales     14,378,560       15,670,109       58,463,859       64,973,157  
    Gross Profit (Loss)     1,111,765       1,184,150       2,838,942       (1,584,540 )
    Selling and Marketing     1,901,185       288,170       9,050,033       1,004,584  
    General and Administrative     4,657,277       7,612,086       20,997,948       22,077,720  
    Settlement Expense, net of Reimbursement                 430,000       1,030,000  
    Research and Product Development     1,955,964       1,608,823       6,886,251       5,642,317  
    Research and Development - Licenses Acquired (Related Party)           1,100,000             1,100,000  
    Operating Loss     (7,402,661 )     (9,424,929 )     (34,525,290 )     (32,439,161 )
                             
    Other Income (Expense)                        
    Realized Gain (Loss) on Investments     5,890       (325 )     30,182       (222,338 )
    Interest Income     94,341       48,932       367,077       535,328  
    Other Expense           410             313  
    Foreign Currency Gain                        
    Total Other Income     100,231       49,017       397,259       313,303  
                             
    Net Loss   $ (7,302,430 )   $ (9,375,912 )   $ (34,128,031 )   $ (32,125,858 )
                             
                             
    Basic and Diluted Net Loss per Share   $ (0.11 )   $ (0.17 )   $ (0.56 )   $ (0.61 )
                             
    Basic and Diluted Weighted Average Shares Outstanding     64,450,030       56,041,350       60,918,544       52,824,486  
                             

     

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  25. WIXOM, Mich., March 11, 2020 (GLOBE NEWSWIRE) -- 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 its Board of Directors has determined that Medical Resource Acquisition Group LLC (MRAG) failed to properly deliver a notice of director nominations under the Company's Bylaws within the prescribed advance notice period. As such, their three director nominees will not stand for election at the 2020 annual meeting of stockholders.

    Based on public records, MRAG is an entity that came into existence only three weeks ago and the Company is not aware of it having any operating…

    WIXOM, Mich., March 11, 2020 (GLOBE NEWSWIRE) -- 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 its Board of Directors has determined that Medical Resource Acquisition Group LLC (MRAG) failed to properly deliver a notice of director nominations under the Company's Bylaws within the prescribed advance notice period. As such, their three director nominees will not stand for election at the 2020 annual meeting of stockholders.

    Based on public records, MRAG is an entity that came into existence only three weeks ago and the Company is not aware of it having any operating history. Nor has the Company been able to locate any filings made by it with securities regulators. Neither MRAG nor Mr. Shroff are stockholders of record, a pre-requisite under our Bylaws to submit director nominations. MRAG has a website that the Company believes went live in the last few days. The Company advises shareholders to exercise caution in reviewing any MRAG communications.

    Gibson, Dunn & Crutcher LLP is acting as legal counsel to Rockwell Medical.

    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.

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    Forward-Looking Statements

    This press release may contain statements which may be considered forward-looking within the meaning of the U.S. federal securities laws. These statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ materially from results expressed or implied in this press release. Additional information is contained in the Risk Factors sections of Rockwell's most recent reports filed with the SEC on Form 10-K and Form 10-Q. Rockwell does not intend to update these forward-looking statements as a result of future events or developments.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  26. WIXOM, Mich., March 10, 2020 (GLOBE NEWSWIRE) -- 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 issued the following statement in response to communications publicly disseminated yesterday by an entity named "Medical Resource Acquisition Group LLC" (MRAG), which purports to be a Rockwell Medical stockholder.

    The Company issued the following statement:

    "Rockwell Medical has received certain email communications from an entity named "Medical Resource Acquisition Group LLC", which purports to be a Rockwell Medical stockholder owning 10,000 shares and seeking to nominate three individuals…

    WIXOM, Mich., March 10, 2020 (GLOBE NEWSWIRE) -- 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 issued the following statement in response to communications publicly disseminated yesterday by an entity named "Medical Resource Acquisition Group LLC" (MRAG), which purports to be a Rockwell Medical stockholder.

    The Company issued the following statement:

    "Rockwell Medical has received certain email communications from an entity named "Medical Resource Acquisition Group LLC", which purports to be a Rockwell Medical stockholder owning 10,000 shares and seeking to nominate three individuals for election to our Board at the 2020 annual meeting of stockholders. The Board of Directors is in the process of reviewing the materials submitted by MRAG. Stockholders do not need to take any action at this time."

    The 2020 annual meeting of Rockwell Medical stockholders has not yet been scheduled. The Company's Board of Directors will present its formal recommendation to stockholders regarding director nominations in the Company's proxy statement.

    Gibson, Dunn & Crutcher LLP is acting as legal counsel to Rockwell Medical.

    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.

    Triferic® is a registered trademark of Rockwell Medical, Inc.

    Forward-Looking Statements

    This press release may contain statements which may be considered forward-looking within the meaning of the U.S. federal securities laws. These statements are subject to known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to differ materially from results expressed or implied in this press release. Additional information is contained in the Risk Factors sections of Rockwell Medical's most recent reports filed with the SEC on Form 10-K and Form 10-Q. Rockwell Medical does not intend to update these forward-looking statements as a result of future events or developments.

    Contact
    Investor Relations:
    Lisa M. Wilson, In-Site Communications, Inc.
    T: 212-452-2793
    E:

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  27. NEW YORK, March 09, 2020 (GLOBE NEWSWIRE) -- Medical Resource Acquisition Group, LLC, (MRAG), an investment firm focused on disruptive technologies in the healthcare space, offered Rockwell Medical, Inc. (NASDAQ:RMTI), on February 25, 2020, equity funding of $15 million for the board seats of current Directors John Cooper, Mark Ravich and Lisa Colleran, who may (or may not) be put up for reelection at the Company's upcoming annual shareholder meeting (see attached letter here).

    MRAG believes the Rockwell Medical management team and Board of Directors' failure to provide appropriate governance has led to reckless spending, a cash deficiency and a lack of operational controls resulting in poor stock performance. Part of the group who has overseen…

    NEW YORK, March 09, 2020 (GLOBE NEWSWIRE) -- Medical Resource Acquisition Group, LLC, (MRAG), an investment firm focused on disruptive technologies in the healthcare space, offered Rockwell Medical, Inc. (NASDAQ:RMTI), on February 25, 2020, equity funding of $15 million for the board seats of current Directors John Cooper, Mark Ravich and Lisa Colleran, who may (or may not) be put up for reelection at the Company's upcoming annual shareholder meeting (see attached letter here).

    MRAG believes the Rockwell Medical management team and Board of Directors' failure to provide appropriate governance has led to reckless spending, a cash deficiency and a lack of operational controls resulting in poor stock performance. Part of the group who has overseen the destruction in value of the RMTI share price includes, John Cooper, Mark Ravich and Lisa Colleran, who have been a distraction for the Board and have hindered the conception, adoption and execution of a much needed dynamic and innovative strategy for Rockwell Medical. Director Ben Wolin resigned from his position on
    February 28, 2020, three days after the Company received the $15 million offer and notice of a possible proxy battle from MRAG.

    Mr. Khurram Shroff, General Partner of MRAG, stated, "Along with our generous offer to fund Rockwell with $15 million, we filed our slate of three high-quality directors with Rockwell and met the requirement of demonstrating the share ownership to do so. We have been taking a significant ownership position in Rockwell and we plan to acquire approximately an additional five million shares. We prefer to acquire those shares direct from Rockwell for $15 million for the three board seats. We believe the $15 million will provide a substantial and timely equity infusion for the Company and that the three board seats will be lost in a contested election anyway. We expect the Rockwell Board of Directors will exercise their fiduciary duty, do what is best for shareholders and accept our offer, avoiding an expensive proxy fight the Company cannot afford for three director seats they will lose anyway". Mr. Shroff also stated, "We believe a $15 million cash infusion and a well-respected, truly independent Board will put Rockwell on the pathway to tremendous success and remove the overhang on the share price."

    As of today, the Rockwell Medical Board of Directors has not accepted or declined MRAG's $15 million dollar offer.

    The Directors that MRAG will nominate for election at the Rockwell Medical annual shareholder meeting are as follows:

    Mr. Khurram Shroff, the General Partner of Medical Resource Acquisition Group LLC. Mr. Shroff, age 41, lives in Toronto, Canada. He is the Chairman of Imperial asset management company, a Canadian asset manager of commercial real estate, since 2015. He is the Chairman of the IBC Group Limited, a Dubai-based investment firm and the general partner of Gallery Suites Vacation Rental LLC, a Dubai based holiday home company with assets under management of US$3 billion, since 2019. Mr. Shroff is also the Chairman of Regal Global Trading with a reach in 70 countries since 2016. He is affiliated with the Shroff Multi Family Office, a global network of independently and privately held family owned assets in over 16 countries with 46 offices. The Shroff Family are considered one of the world's oldest Guajarati business families.

    Mr. Arthur S. Reynolds has more than 35 years of experience raising capital in Europe for clients located in the U.S. Mr. Reynolds is a Managing Director of Rexon Limited, which he founded in 1995 and through which he has since raised capital for more than 50 companies. Mr. Reynolds commenced his career with Mobil Corporation and then held a position at W.R. Grace and Co. (which sold National Medical Care, world's largest operator of kidney disease treatment centers in 1996 to Fresenius A.G. for $4.4 billion). He joined Morgan Guaranty Trust Company's Corporate Finance Department and later, he and others founded the Interfunding unit of J.P. Morgan & Co. In 1978, he began a 27-year career in London raising capital for U.S. clients, first as an officer of Merrill Lynch International Bank Limited and subsequently, as the founder of Ferghana Financial Services Ltd in 1982, at the behest of Sir James Goldsmith for whose operations Mr. Reynolds raised more than $300 million. Mr. Reynolds served on the Board of Directors of ThermoEnergy Corporation for 14 years, where he was Chairman of the Board from 2014-2016, and Chairman of the Audit Committee from 2001 to 2006 and again from 2009-2013.

    Mr. Markus Müller is currently a member of the Board of Directors of Arundel AG, an investment services firm based in Zurich providing specialist investment banking and investment management, financial advisory services to family offices, and fund management groups across developed and emerging markets. Mr. Müller commenced his professional career working for Credit Suisse. From 2000 to 2018, Mr. Müller served in the executive management of Scherrer & Partner Investment Management AG (Zurich), a company involved in asset management for private clients and the management of investment funds. From 1995 to 2000, Mr. Müller served in the management of Jefferies (Switzerland) Ltd and as the general manager of Jefferies Asset Management AG (Zug).

    Medical Resource Acquisition Group LLC managed by Khurram Shroff, General Partner. Chief Medical Advisor Dominic Man-Kit Lam, a D.Phil in Medical Biophysics from University of Toronto. He then joined as a Professor of Ophthalmology at Harvard Medical School. In 1985, Lam started the first biotech company in Texas and subsequently took it public in U.S. and was named "The Father of Texas Biotechnology". He also became the  Director of Center for Biotechnology in Houston, Texas. Lam later founded and directed the Hong Kong Institute of Biotechnology. Lam is currently the Chairman and Chief Biomedical Officer of Rejuve Longevity Network. He also founded World Eye Organization (WEO) to prevent and treat eye diseases for the poor. Lam received the U.S. High Tech Entrepreneur of the Year Award in 1989, and the U.S. Presidential Medal of Merit. He was also appointed a member of the U.S. President's Committee on the Arts and Humanities. In 2001, Lam's patent on "Edible Vaccine" was named by MIT as one of "Five patents that will transform business and technology", and by Time Magazine as one of ten most important inventions in the 21st century.

    Forward Looking Statements

    Certain information set forth in this presentation contains "forward-looking information", including "future oriented financial information" and "financial outlook", under applicable securities laws (collectively referred to herein as forward looking statements). These forward-looking statements are based on current expectations, estimates, forecasts and projections. Words such as "expect," "anticipate," "should," "believe," "hope," "target," "project," "goals," "estimate," "potential," "predict," "may," "will," "might," "could," "intend," "shall" and variations of these terms or the negative of these terms and similar expressions are intended to identify these forward-looking statements. Forward looking statements are subject to a number of risks and uncertainties, many of which involve factors or circumstances that are beyond MRAG's control.

    These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause events to differ materially from any expectations or projections of future performance or result expressed or implied by such forward looking statements. These risks include, among other things: (i) market perception regarding MRAG and the viability of the proposed transactions; (ii) the availability of financing for the proposed transaction with Rockwell Medical; and (iii) the recent outbreak of the novel coronavirus and the global impact it may have on financial markets and the life sciences sector.

    Although forward-looking statements contained in this presentation are based upon what management of MRAG believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. MRAG undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

    Additional Information and Where to Find It

    This communication may be deemed to be solicitation material in respect of the 2020 Annual Meeting of Rockwell Medical, Inc.. In connection with the 2020 Annual Meeting, MRAG intends to file relevant materials with the SEC, including a proxy statement on Schedule 14A. STOCKHOLDERS OF ROCKWELL ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING MRAG'S PROXY STATEMENT, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED CANDIDATES. Investors and security holders will be able to obtain the documents free of charge at the SEC's web site. Such documents are not currently available.

    Participants in Solicitation

    For further information please contact Medical Resource Acquisition Group LLC | https://www.mragworld.com/ or email

    For Media
    Tien Ma

    c/o Redhill Communications
    011 49 163 835 8774

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  28. WIXOM, Mich., March 04, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. ("Rockwell Medical" or the "Company") (NASDAQ:RMTI) today announced that the Company will release its 2019 fourth quarter and full year financial results on Thursday, March 12, 2020, after the close of the U.S. financial markets.

    Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date
    Time
    Toll free (U.S.)
    International
    Webcast (live and replay)
    Thursday, March 12, 2020
    4:30 p.m. ET
    (877) 383-7438
    (678) 894-3975
    www.rockwellmed.com under the "Investor" section

    The webcast will be archived for 30 days at the aforementioned URL. 

    About Rockwell Medical

    Rockwell Medical is a biopharmaceutical…

    WIXOM, Mich., March 04, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. ("Rockwell Medical" or the "Company") (NASDAQ:RMTI) today announced that the Company will release its 2019 fourth quarter and full year financial results on Thursday, March 12, 2020, after the close of the U.S. financial markets.

    Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date
    Time
    Toll free (U.S.)
    International
    Webcast (live and replay)
    Thursday, March 12, 2020
    4:30 p.m. ET
    (877) 383-7438
    (678) 894-3975
    www.rockwellmed.com under the "Investor" section

    The webcast will be archived for 30 days at the aforementioned URL. 

    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, 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; the timing and regulatory approval process for our NDA filing for I.V. Triferic as filed with the FDA: the potential market opportunity for I.V. Triferic, 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; our ability to successfully commercialize Dialysate Triferic, 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 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: 212-452-2793
    E:

    Source: Rockwell Medical, Inc.

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    • Company appoints Andrew M. Baker, Jane Okun Bomba, John A. Meyer, and Robin L. Smith
    • Additions expand ServiceSource's Board with respected world-class leaders
    • Planned retirement of three directors at the conclusion of their term

    ServiceSource (NASDAQ:SREV), the digital customer journey experience company, announced today the appointment of Andrew (Andy) M. Baker, Jane Okun Bomba, John A. Meyer, and Robin L. Smith to the Company's Board of Directors, effective immediately. The Company also announced that independent directors Robert G. Ashe, Bruce W. Dunlevie, and Thomas F. Mendoza intend to retire from service on the Board at the expiration of their current terms and will not stand for re-election at ServiceSource's 2020 Annual Meeting…

    • Company appoints Andrew M. Baker, Jane Okun Bomba, John A. Meyer, and Robin L. Smith
    • Additions expand ServiceSource's Board with respected world-class leaders
    • Planned retirement of three directors at the conclusion of their term

    ServiceSource (NASDAQ:SREV), the digital customer journey experience company, announced today the appointment of Andrew (Andy) M. Baker, Jane Okun Bomba, John A. Meyer, and Robin L. Smith to the Company's Board of Directors, effective immediately. The Company also announced that independent directors Robert G. Ashe, Bruce W. Dunlevie, and Thomas F. Mendoza intend to retire from service on the Board at the expiration of their current terms and will not stand for re-election at ServiceSource's 2020 Annual Meeting of Stockholders.

    "We are very pleased to welcome Andy, Jane, John, and Robin as new independent directors to ServiceSource's Board," said Gary B. Moore, ServiceSource's chairman and chief executive officer. "Their proven track records and collective expertise will be immensely valuable as we execute our long-term strategy. They will be a strong complement to the experience and skills of our existing board members, and we look forward to benefiting from their contributions and unique perspective. We are thrilled they have chosen to join ServiceSource at an exciting time in our transformation journey, as we continue our progress strengthening the Company's fundamentals to enable a return to profitable growth."

    The Company's Board of Directors routinely evaluates its structure to ensure that ServiceSource has an appropriately diverse, skilled, and actively engaged Board with the requisite depth and composition to ensure long-term value realization. With the appointment of these four new directors, ServiceSource has refreshed its Board with six new independent directors since the beginning of 2019.

    "In addition to welcoming the new directors, we also extend our appreciation to Rob, Bruce, and Tom for their years of service to the Company," continued Moore. "Their vision and leadership have been instrumental in building ServiceSource into a global market leader that drives the customer journey experience for many of the world's most recognizable technology brands. Their efforts on behalf of ServiceSource and our stockholders have repositioned the Company to better capitalize on the attractive growth and value creation opportunities in front of us."

    Andy Baker is the immediate past Managing Partner of Baker Botts, an Am Law 100 law firm with operations in 14 cities across the United States, Europe, the Middle East and Asia Pacific. As a practicing attorney for more than 30 years, Mr. Baker worked closely with a number of Fortune 100 companies as a strategic and trusted advisor. In addition to ServiceSource, he serves on the board of directors of private equity-backed McLarens, a global loss adjusting company. Mr. Baker will join ServiceSource's Audit Committee and Nominating and Governance Committee.

    Jane Okun Bomba is President of Saddle Ridge Consulting and advises companies on a range of strategic issues, including investor relations, corporate perception and governance, transaction integration, human resources, and ESG. From 2004 to 2017, she was an executive at IHS Markit (NYSE:INFO), most recently serving as the Executive Vice President, Chief Administrative Officer, where she led large transformational initiatives. In addition to ServiceSource, Ms. Okun Bomba serves on the board of directors of Brightview Holdings (NYSE:BV) and Kickstart International. She will serve as chair of ServiceSource's Compensation Committee and will join the Audit Committee.

    John Meyer most recently served as the Executive Chairman of Arise Virtual Solutions Inc., until its successful exit to Warburg Pincus in December 2019. Prior to joining Arise, Mr. Meyer served as chief executive officer and president of Acxiom Corporation (NASDAQ:ACXM), as president of the Global Services group of Alcatel-Lucent (NYSE:ALU), and as a senior executive for nearly 20 years at Electronic Data Systems (EDS). Mr. Meyer will chair ServiceSource's Nominating and Governance Committee and will join the Audit Committee.

    Dr. Robin Smith is a successful executive and board advisor, and currently serves on the board of directors of Sorrento Therapeutics (NASDAQ:SRNE), Seelos Therapeutics (NASDAQ:SEEL), and Celularity Inc. Dr. Smith has also served as chairman of the board of directors of MYnd Analytics, Inc. (NASDAQ:MYND), on the board of directors of Rockwell Medical (NASDAQ:RMTI), Signal Genetics (NASDAQ:SGNL), and BioXcel Corporation, and was chairman and chief executive officer of Neostem (now Caladrius Biosciences). She will join ServiceSource's Nominating and Governance Committee.

    About ServiceSource

    ServiceSource International, Inc. (NASDAQ:SREV) brings the world's greatest brands closer to their customers through digitally-enabled solutions and data-driven insights that personalize and power the "moments that matter". Backed by 20 years of experience, an industry-leading technology platform, a robust global footprint and a powerful suite of solutions that enhance every touchpoint along the Customer Journey Experience (CJX), we deliver impactful revenue growth for global market leaders. Operating out of eight countries with more than 3,000 sales delivery professionals speaking 45 languages, ServiceSource drives billions of dollars in client value annually. To learn more about how we help our clients more effectively find, convert, nurture, grow and retain their customers, visit www.servicesource.com.

    Connect with ServiceSource:

    Facebook

    Twitter

    LinkedIn

    YouTube

    Trademarks

    ServiceSource®, and any ServiceSource product or service names or logos above are trademarks of ServiceSource International, Inc. All other trademarks used herein belong to their respective owners.

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  29. -- Continued progress for Triferic® portfolio --
    -- 77% increase in the number of clinics under contract --

    WIXOM, Mich., Feb. 27, 2020 (GLOBE NEWSWIRE) -- 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 provided a business update and information related to the launch of Dialysate Triferic® (ferric pyrophosphate citrate).

    Key Business Updates and Highlights for the Quarter Ended December 31, 2019

    • 77% sequential-quarter increase in the number of clinics contracted to purchase Dialysate Triferic, and a 67% increase in the number of annualized treatments under contract.

    • 75% of the clinics…

    -- Continued progress for Triferic® portfolio --
    -- 77% increase in the number of clinics under contract --

    WIXOM, Mich., Feb. 27, 2020 (GLOBE NEWSWIRE) -- 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 provided a business update and information related to the launch of Dialysate Triferic® (ferric pyrophosphate citrate).

    Key Business Updates and Highlights for the Quarter Ended December 31, 2019

    • 77% sequential-quarter increase in the number of clinics contracted to purchase Dialysate Triferic, and a 67% increase in the number of annualized treatments under contract.

    • 75% of the clinics that completed an Evaluation Program for Dialysate Triferic in the fourth quarter have converted to commercial customers.

    • Signed an agreement with a Medium-Sized Dialysis Organization (MDO) for the purchase of Dialysate Triferic in late November 2019. As of December 31, 2019, five clinics within this MDO had purchased Dialysate Triferic, and Rockwell Medical expects clinic adoption to accelerate during the first half of 2020. Approximately 160 clinics within the MDO are candidates for Dialysate Triferic.

    • Strengthened and expanded medical capabilities, including the hiring of Marc Hoffman, MD, as Chief Medical Officer, appointment of Russell Ellison, MD, to the Board of Directors, and the appointment of three world-renowned nephrologists to the Company's Medical Advisory Board.

    "We are encouraged by the positive trends in adoption we are seeing as we roll out the Triferic platform in the U.S. The recent signing of a Medium-Sized Dialysis Organization is a meaningful accomplishment, as it extends our reach in transforming anemia management for hemodialysis patients and represents a sizable sales opportunity. To support our commercial activities, we continue to build out our medical capabilities through the additions of prominent anemia and ESRD experts to our management team, Board of Directors and Medical Advisory Board. Our near-term efforts remain focused on driving adoption of our innovative therapeutic and to ensuring that Triferic is available to the patients who can benefit," stated Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    Rockwell Medical will host its quarterly earnings call on March 12, 2020, at which time it will provide a more detailed business update and discuss financial results for the three and twelve months ended December 31, 2019.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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.

    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: 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: 212-452-2793
    E:

    Source: Rockwell Medical, Inc.

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  30. WIXOM, Mich., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, will present at the 2020 BIO CEO & Investor Conference as follows:

    Date: Monday, February 10, 2020
    Time: 9:15 a.m. Eastern Time
    Location: New York Marriott Marquis, New York, NY
    Webcast: http://www.veracast.com/webcasts/bio/ceoinvestor2020/62104182.cfm

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the Investors section.

    To schedule a one-on-one meeting with management, please contact Lisa Wilson at .

    About Rockwell Medical

    Rockwell…

    WIXOM, Mich., Feb. 06, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, will present at the 2020 BIO CEO & Investor Conference as follows:

    Date: Monday, February 10, 2020
    Time: 9:15 a.m. Eastern Time
    Location: New York Marriott Marquis, New York, NY
    Webcast: http://www.veracast.com/webcasts/bio/ceoinvestor2020/62104182.cfm

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the Investors section.

    To schedule a one-on-one meeting with management, please contact Lisa Wilson at .

    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, 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," "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: 212-452-2793
    E:

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  31. WIXOM, Mich., Feb. 04, 2020 (GLOBE NEWSWIRE) -- 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…

    WIXOM, Mich., Feb. 04, 2020 (GLOBE NEWSWIRE) -- 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: .

    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: 212-452-2793
    E:

    Primary Logo

    View Full Article Hide Full Article
  32. WIXOM, Mich., Feb. 03, 2020 (GLOBE NEWSWIRE) -- 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 an underwritten public offering of its common stock. In addition, Rockwell Medical has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    Rockwell Medical anticipates using the net proceeds from the offering for the commercialization of Dialysate Triferic and I.V. Triferic, research and development…

    WIXOM, Mich., Feb. 03, 2020 (GLOBE NEWSWIRE) -- 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 an underwritten public offering of its common stock. In addition, Rockwell Medical has granted the underwriter a 30-day option to purchase up to an additional 15% of the number of shares of its common stock offered in the public offering.

    Cantor Fitzgerald & Co. is acting as the sole book-running manager for the offering.

    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 related to the offering will be filed with the SEC and will be available on the SEC's website at www.sec.gov.  Copies of the preliminary 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: .

    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, 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," "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: 212-452-2793
    E:

    Primary Logo

    View Full Article Hide Full Article
  33. WIXOM, Mich., Jan. 14, 2020 (GLOBE NEWSWIRE) -- 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 license and supply agreements with a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. (together, "Sun Pharma"), for the rights to commercialize Triferic (ferric pyrophosphate citrate) in India.

    Under the terms of the agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic in India and Rockwell Medical will supply the product to Sun Pharma. In consideration for the license, Rockwell Medical will receive…

    WIXOM, Mich., Jan. 14, 2020 (GLOBE NEWSWIRE) -- 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 license and supply agreements with a wholly-owned subsidiary of Sun Pharmaceutical Industries Ltd. (together, "Sun Pharma"), for the rights to commercialize Triferic (ferric pyrophosphate citrate) in India.

    Under the terms of the agreements, Sun Pharma will be the exclusive development and commercialization partner for Triferic in India and Rockwell Medical will supply the product to Sun Pharma. In consideration for the license, Rockwell Medical will receive an upfront fee, and will be eligible for milestone payments and royalties on net sales.

    Sun Pharma is the largest pharmaceutical company in India, with more than $4 billion in annual sales globally. Sun Pharma will leverage its market leading nephrology franchise to promote Triferic to nephrologists in India. A Joint Alliance Committee, comprised of members from Rockwell Medical and Sun Pharma, will guide the development and execution for Triferic in India. Sun Pharma will be responsible for all clinical, regulatory and commercialization activities.

    "We are pleased to establish this important relationship with Sun Pharma, which has a strong presence in the nephrology segment in India. With a dedicated business unit, market leading sales force and medical support personnel, together with its experience with license and distribution partnerships with large global pharmaceutical companies, Sun Pharma is well positioned to ensure that hemodialysis patients have access to our innovative therapeutic. This is a meaningful advancement for Triferic as we expand our global footprint and drive the long-term value of Triferic," said Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    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. Please visit www.rockwellmed.com for more information.

    About Sun Pharmaceutical Industries Ltd. (CIN - L24230GJ1993PLC019050)
    Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R&D capabilities across multiple R&D centers, with investments of approximately 7% of annual revenues in R&D. For further information, please visit www.sunpharma.com & follow us on Twitter @SunPharma_Live.

    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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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 bring to market Triferic, and I.V. Triferic. 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; CMS' announced final rule relating to eligibility criteria for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc

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  34. WIXOM, Mich., Jan. 09, 2020 (GLOBE NEWSWIRE) -- 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, announced today the appointment of Russell H. Ellison, MD, MSc, to its Board of Directors, effective January 9, 2020.

    Dr. Ellison has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades. His broad experience includes board of director, chief executive and medical executive roles, with expertise in medical strategy, clinical development, global medical affairs, regulatory affairs and public health policy in major markets and developing…

    WIXOM, Mich., Jan. 09, 2020 (GLOBE NEWSWIRE) -- 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, announced today the appointment of Russell H. Ellison, MD, MSc, to its Board of Directors, effective January 9, 2020.

    Dr. Ellison has held leadership positions in both emerging biotechnology and large pharmaceutical companies for more than four decades. His broad experience includes board of director, chief executive and medical executive roles, with expertise in medical strategy, clinical development, global medical affairs, regulatory affairs and public health policy in major markets and developing countries.  Dr. Ellison has a deep understanding of the renal space based on experiences with companies developing therapeutic products that address kidney disease and renal anemia, including Hypoxia-inducible factor (HIF) prolyl hydroxylase (PH) inhibitors.

    "Russell's broad industry experience with public biotechnology companies and especially his extensive knowledge of the renal and anemia space makes him an ideal addition to our Board. His leadership will serve us well as we commercialize and develop Triferic® (ferric pyrophosphate citrate) for hemodialysis patients around the world, implement our plans for building a leading medical organization, and further the clinical development of our therapeutic platform as we seek to transform the way anemia is managed in a variety of disease states," stated John P. McLaughlin, Chairman of the Board of Directors of Rockwell Medical.

    "It is an honor to join Rockwell Medical's Board and to have the opportunity to contribute to the advancement of such an innovative therapeutic. There is a global opportunity for Triferic® (ferric pyrophosphate citrate), and I am eager to work alongside the current Board members and management team to guide the path forward and ensure that patients have access to this unique iron maintenance therapy," said Russell H. Ellison, MD, MSc.

    Dr. Ellison's broad experience and leadership positions include Chief Executive Officer of the privately held biotechnology company, Promedior, Inc., which focused on, among other indications, kidney fibrosis, and successfully completed the company's strategic sale in December 2018; President and CEO 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 global investment banking boutique serving companies in the life sciences industry; Chairman and CEO of Assembly Biosciences, Inc. (formerly, Ventrus Biosciences, Inc.); Executive Vice President of Paramount Biosciences LLC, Vice President of Clinical Development at FibroGen, Inc. where he played a key role in the completion of a phase 2 trial with a HIF-PH inhibitor in anemia for Chronic Kidney Disease (CKD) patients; Vice President of Medical Affairs and Chief Medical Officer of Sanofi-Synthelabo, Inc.; and Vice President, Medical Affairs and Chief Medical Officer of Hoffman La Roche, Inc.  Additionally, Dr. Ellison has previously served as an Independent Board Director for several private and public companies including, among others, Cougar Biotechnology Inc., ProSanos Corporation, Cormedix Inc., a cardio-renal clinical stage company, and Mt. Cook, a urology-focused company.

    Dr. Ellison received an MSc from The London School of Tropical Medicine and Hygiene, and an MD from the University of British Columbia.

    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, 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. Please visit www.rockwellmed.com for more information.

    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 provide significant benefits to 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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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 bring to market Triferic, and I.V. Triferic. 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; CMS' announced final rule relating to eligibility criteria for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    Primary Logo

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  35. WIXOM, Mich., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will present at the Biotech Showcase 2020 as follows: 

       
    Date: Wednesday, January 15, 2020
    Time: 11:00 a.m. Pacific Standard Time
    Location: Hilton San Francisco Union Square, San Francisco, CA
       
    Webcast:  https://event.webcasts.com/starthere.jsp?ei=1279094&tp_key=02ada989b7
       

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical
    Rockwell Medical is a biopharmaceutical…

    WIXOM, Mich., Jan. 08, 2020 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will present at the Biotech Showcase 2020 as follows: 

       
    Date: Wednesday, January 15, 2020
    Time: 11:00 a.m. Pacific Standard Time
    Location: Hilton San Francisco Union Square, San Francisco, CA
       
    Webcast:  https://event.webcasts.com/starthere.jsp?ei=1279094&tp_key=02ada989b7
       

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    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. Please visit www.rockwellmed.com for more information.

    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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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 bring to market Triferic, and I.V. Triferic. 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; CMS' announced final rule relating to eligibility criteria for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    Primary Logo

    View Full Article Hide Full Article
  36. WIXOM, Mich., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference as follows: 

    Date: Tuesday, December 3, 2019
    Time: 12:00 p.m. Eastern Standard Time
    Location: Lotte New York Palace, New York, NY
    Webcast: https://event.webcasts.com/starthere.jsp?ei=1273475&tp_key=a58ce392ac

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    About Rockwell Medical
    Rockwell Medical is a biopharmaceutical company dedicated to transforming anemia management…

    WIXOM, Mich., Nov. 21, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company") today announced that Stuart Paul, Chief Executive Officer, will present at the 31st Annual Piper Jaffray Healthcare Conference as follows: 

    Date: Tuesday, December 3, 2019
    Time: 12:00 p.m. Eastern Standard Time
    Location: Lotte New York Palace, New York, NY
    Webcast: https://event.webcasts.com/starthere.jsp?ei=1273475&tp_key=a58ce392ac

    The presentation will be webcast live at the aforementioned time, and archived for 30 days thereafter, via the Company's website at www.rockwellmed.com, under the "Investors" section.

    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, 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. Please visit www.rockwellmed.com for more information.

    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 provide significant benefits to patients and health care economics. Triferic represents one of the most innovative medical advancements in patient iron management in the past few decades – with the potential to be 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). Unlike traditional IV iron products, 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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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 bring to market Triferic, and I.V. Triferic. 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; the pricing and reimbursement status for I.V. Triferic under CMS' final rule relating to TDAPA as announced by CMS on October 31, 2019; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    Primary Logo

    View Full Article Hide Full Article
  37. – Company adds experienced medical executive to management team and leading nephrologists to Medical Advisory Board –

    – Objective to become a leading medical organization in the field of dialysis –

    WIXOM, Mich., Nov. 20, 2019 (GLOBE NEWSWIRE) -- 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 Company is expanding its medical capabilities, with the initial goal of building a leading medical organization in the field of dialysis. The Company believes that its Triferic® (ferric pyrophosphate citrate) platform has the potential to transform the way anemia is treated in…

    – Company adds experienced medical executive to management team and leading nephrologists to Medical Advisory Board –

    – Objective to become a leading medical organization in the field of dialysis –

    WIXOM, Mich., Nov. 20, 2019 (GLOBE NEWSWIRE) -- 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 Company is expanding its medical capabilities, with the initial goal of building a leading medical organization in the field of dialysis. The Company believes that its Triferic® (ferric pyrophosphate citrate) platform has the potential to transform the way anemia is treated in end-stage renal disease (ESRD) patients. As a result, the Company is making investments in its medical organization, real-world data and medical educational programs, and clinical development capabilities. 

    Through the ongoing development and commercialization of Dialysate Triferic, and in preparation for the potential approval of I.V. Triferic in 2020, the Company has identified the following key medical priorities to establish and position Triferic as the standard of care in anemia over the next three to five years:

    • Development of relationships with Centers of Excellence to assist the Company with real- world data collection, education of the dialysis community, and guidance for various aspects of anemia management and the use of Triferic;
    • Collection and analysis of additional retrospective and prospective data to support the real-world impact of Triferic on clinical and health-economic outcomes;
    • Enhancement of, and investment in, the Company's medical affairs capabilities, including engagement with Key Opinion Leaders (KOLs), increased interaction with patient and physician advocacy groups, data publications and abstracts to drive expanded awareness of Triferic;
    • Expansion of the Company's medical education capabilities to challenge an entrenched standard of care and educate clinicians about the unique scientific attributes and benefits of Triferic; and
    • Addition of global clinical development expertise to: (1) guide the development of Triferic in key geographies in collaboration with current and future partners; and (2) further explore the clinical and pharmacoeconomic attributes of Triferic to address anemia in ESRD and other medical indications.

    With the establishment of these priorities, Rockwell Medical has appointed Marc Hoffman, MD as Chief Medical Officer (CMO). Dr. Hoffman's skillset will complement the Company's existing medical capabilities and enable the Company to drive these key medical priorities. Dr. Hoffman has extensive experience building and providing medical affairs and clinical development capabilities for pharmaceutical companies, through both in-house roles at companies such as Baxter and Hospira and in senior leadership positions at various contract research organizations (CROs), including Covance and, most recently, Celerion Inc. Throughout his distinguished 30-year career, Dr. Hoffman has established medical affairs capabilities in order to harness the data needed to develop and commercialize pharmaceutical products worldwide. The Company believes that Dr. Hoffman's expertise will further complement and enable the Company to accelerate the execution of the Company's key medical initiatives.

    Dr. Raymond Pratt, the Company's current CMO, will transition to a new role as Chief Development Officer. In this role, Dr. Pratt will be responsible for managing the global clinical development and regulatory approval pathway of Triferic in ESRD. Dr. Pratt has significant experience in drug development in nephrology, including leading the development and FDA approval of Dialysate Triferic. Specifically, Dr. Pratt will continue to work on the New Drug Application for I.V. Triferic, which is currently under review by the FDA with a PDUFA date of March 28, 2020, and the development and regulatory submission for Triferic in various countries across the globe in coordination with the Company's partners.

    Dr. Ajay Gupta, the Company's Chief Scientific Officer, will continue to focus on the scientific foundation and applications of the Triferic platform. As a nephrologist with deep knowledge of the physiology of anemia and in the mechanism of action of Triferic, Dr. Gupta works closely with worldwide KOLs in anemia to advance clinical approaches to improve patient outcomes.

    In addition, Rockwell Medical is adding several leading nephrologists to its Medical Advisory Board. The members of the Medical Advisory Board will provide critical advice to the Company as it seeks to accomplish the goals identified above. The additions include:

    • Steven Fishbane, MD, Chief of Nephrology of Northwell Health and Professor of Medicine at the Zucker School of Medicine. Dr. Fishbane is a nephrologist with over 25 years of clinical experience and over 24 years as a medical researcher with more than 210 peer-reviewed publications. He has received multiple honors and holds several appointments, including to the National Quality Forum's Standing Committee of Admissions and Readmissions. Through his clinical research, Dr. Fishbane has become renowned for advancement and innovation in the treatment of chronic kidney disease patients.
    • Jay Wish, MD, Professor of Clinical Medicine at Indiana University School of Medicine in Indianapolis and Chief Medical Officer for Dialysis at Indiana University Health. Dr. Wish has a distinguished career in the field of nephrology and dialysis, which includes serving on the Board of Directors of Renal Physicians Association and the American Association of Kidney Patients (AAKP), where he received AAKP's Visionary Award in 2005. Dr. Wish is Vice Chairman of the Editorial Advisory Board for Nephrology News & Issues and serves on the editorial boards of the Journal of the American Society of Nephrology and Clinical Journal of the American Society of Nephrology. At the American Society of Nephrology Conference on November 8, 2019, Dr. Wish presented on Triferic in a symposium entitled "Advances in Hemodialysis-Associated Anemia Management: The Benefits of Physiologic Iron Replacement Therapy."
    • Anatole Besarab, MD, a nephrologist who has served as the Chair and Co-Chair of the NKF Workgroup on Vascular Access. Dr. Besarab has also served on various committees for the FORUM of ESRD networks, the ASN, NKF, ASAIO, and the NIH. He is the author of more than 215 peer reviewed papers, 28 chapters, and 17 monographs. His work has focused primarily on optimizing the management of anemia, particularly on the proper balance between erythropoiesis and iron delivery. He has also served as lead investigator on clinical trials involving HIF-PHI inhibitors.  

    "To achieve our goal of transforming anemia management for dialysis patients, we are making specific investments in our medical expertise, real world and clinical data, as well as medical education programs," said Stuart Paul, President and Chief Executive Officer of Rockwell Medical. "We are thrilled to welcome Dr. Hoffman to our executive leadership team, and we expect his proven track record in building, managing and globalizing medical teams and expertise in data management will be an asset as we position our Company for growth. In parallel, I am delighted that we have assembled a Medical Advisory Board of world-renowned experts in anemia and ESRD who can contribute their significant experience to help guide the further development and commercialization of Triferic," concluded Mr. Paul.

    "I am delighted to join the Rockwell Medical team at this pivotal time and to lead the effort to expand the Company's real-world evidence dataset, educate the renal community about the innovative attributes of Triferic in managing anemia in ESRD patients, and advance the Company's medical affairs strategy. Triferic, in its various formulations, is innovative and offers both clinical and potential pharmacoeconomic benefits. I look forward to working with Dr. Pratt and Dr. Gupta, while contributing to the development of a strong medical and clinical support team and to advancing adoption of this important therapeutic," stated Dr. Hoffman.

    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, 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. Please visit www.rockwellmed.com for more information.

    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 provide significant benefits to patients and health care economics. Triferic represents one of the most innovative medical advancements in patient iron management in the past few decades – with the potential to be 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). Unlike traditional IV iron products, 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. Please visit www.triferic.com to view the Triferic mechanism-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    Notice of Issuance of Inducement Grants
    Pursuant to his employment agreement, Dr. Hoffman will be awarded stock-based compensation representing the right to acquire shares of common stock (the "Inducement Grants"). The Inducement Grants will consist of options to purchase up to 250,000 shares of common stock, subject to time-based vesting conditions. The Inducement Grants will be issued upon Dr. Hoffman's commencement of employment (the "Grant Date"), and all stock options included within the Inducement Grants will have an exercise price equal to the fair value of the common stock on the Grant Date. The Inducement Grants have been approved by the Company's Board of Directors and the Compensation Committee of the Board of Directors. The Inducement Grants will be issued outside of the Company's shareholder-approved equity incentive plans as an inducement grant, in accordance with Nasdaq Listing Rule 5635(c)(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 bring to market Triferic, and I.V. Triferic. 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 Dialysate Triferic in China; the potential market opportunity and commercialization of Dialysate Triferic in China upon regulatory approval; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; the pricing and reimbursement status for I.V. Triferic under CMS' final rule relating to TDAPA as announced by CMS on October 31, 2019; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the success of our commercialization of Dialysate Triferic, which commenced in May 2019; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    Primary Logo

    View Full Article Hide Full Article
  38. – Company reports first full quarter of results for Dialysate Triferic, highlighted by greater than 75% conversion rate from Triferic Evaluation Program –  
    – Signs leading East Coast academic medical center as first Center of Excellence –

    WIXOM, Mich., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD), today reported business highlights and financial results for the three- and nine-months ended September 30, 2019.

    "Our mission is to transform anemia management in a wide variety of disease states across the globe while improving patients' lives…

    – Company reports first full quarter of results for Dialysate Triferic, highlighted by greater than 75% conversion rate from Triferic Evaluation Program –  
    – Signs leading East Coast academic medical center as first Center of Excellence –

    WIXOM, Mich., Nov. 11, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD), today reported business highlights and financial results for the three- and nine-months ended September 30, 2019.

    "Our mission is to transform anemia management in a wide variety of disease states across the globe while improving patients' lives. We believe Triferic is one of the most innovative advancements in patient iron management over the last two decades. Accordingly, we are building the foundation to become a leading medical and commercial organization in the field of dialysis, which we believe will enable Triferic to become, over time, the standard of care for ESRD patients. We are pleased with the early progress we are making with the commercialization of our Triferic portfolio," stated Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    Recent Business and Financial Highlights:

    • Key highlights for the Dialysate Triferic U.S. market introduction include:
      ○  1,000+ patients on therapy at 13 contracted clinics as of September 30, 2019;
      ○  1,300+ patients on therapy at 15 clinics enrolled in the Evaluation Program;
      ○  Since launch, experienced 75% conversion rate of clinics in Evaluation Program; and
      ○  The Company entered into its first contract with a Center of Excellence1 ("COE") for the purchase of Dialysate Triferic.
    • Appointed industry veteran John P. McLaughlin as Chairman of the Board of Directors, bringing over 30 years of executive and board experience in the biopharmaceutical industry;
    • Continued to engage with the U.S. Food and Drug Administration ("FDA") on review activities regarding the I.V. Triferic New Drug Application ("NDA"), with a PDUFA date of March 28, 2020;
    • Committed to enhancing the Company's medical capabilities to build a leading medical platform in the field of dialysis;
    • Sales were $15.4 million and $45.8 million for the three and nine months ended September 30, 2019, respectively, including sales of Dialysate Triferic of approximately $98,000 and $112,000, respectively; and
    • As of September 30, 2019, the Company had approximately $29.0 million of cash and cash equivalents and investments available-for-sale.

    "We recognize that transforming to a new therapy from a well-entrenched approach takes time. As we build the foundation to achieve our mission, both in the U.S. and internationally, we are off to a promising start, and will continue to dedicate our resources to ensuring that hemodialysis patients have access to this innovative therapeutic," concluded Paul.

    _____________________________
    1 The Company defines Centers of Excellence as leading independent academic institutions that operate their own clinics or leading nephrology practices that are recognized as thought leaders in dialysis.


    Third Quarter 2019 Financial Results

    Net loss for the third quarter of 2019 was $7.9 million, or $0.12 per basic and diluted share, compared to a net loss of $5.0 million, or $0.10 per basic and diluted share, in the third quarter of 2018. The increase in net loss for the third quarter of 2019 compared to the third quarter of 2018 primarily reflects investments in the Company's medical and commercial platform in the field of dialysis to support the commercialization and continued development of Triferic as Rockwell Medical executes on its business plans.

    Net sales for the third quarter of 2019 were $15.4 million compared to sales of $16.7 million during the three months ended September 30, 2018.  Net sales of hemodialysis concentrates to dialysis providers and distributors in the U.S. and abroad were $15.2 million for the three months ended September 30, 2019 compared to $16.6 million for the three months ended September 30, 2018. The decrease of $1.4 million was primarily due to lower sales to international customers, offset by an increase in sales pursuant to the Company's contract with DaVita Inc.  Net sales of Triferic were $166,000 for the three months ended September 30, 2019 compared to $68,000 for the three months ended September 30, 2018. For each of the three months ended September 30, 2019 and September 30, 2018, Triferic net sales included approximately $68,000 of deferred revenue recognized under the Company's license in the People's Republic of China with Wanbang Biopharmaceutical. Triferic net sales for the three months ended September 30, 2019 also included approximately $98,000 of Triferic product sales to U.S. customers.

    Cost of sales during the three months ended September 30, 2019 was $15.4 million compared to cost of sales of a $14.7 million during the three months ended September 30, 2018. Cost of sales for the three months ended September 30, 2019 included $14.3 million of manufacturing and distribution costs associated with the Company's concentrates products, and $1.1 million of inventory reserve expenses and product costs for Triferic, compared to $14.6 million and $0.1 million, respectively, for the three months ended September 30, 2018. Gross loss for the three months ended September 30, 2019 was approximately $16,000 compared to gross profit of $2.0 million for the three months ended September 30, 2018. Gross profit (loss) for the three months ended September 30, 2019 consisted of a gross loss from Triferic of $0.9 million, partially offset by gross profit of $0.9 million for the Company's concentrates products, compared to a gross loss of $0.1 million and gross profit of $2.0 million, respectively, for the three months ended September 30, 2018. 

    Selling and marketing expenses were $1.8 million during the three months ended September 30, 2019 compared with $0.1 million during the three months ended September 30, 2018. The increase of $1.7 million was due to investments the Company is making in developing a commercial platform to support the commercial launch of Triferic.

    General and administrative expenses were $4.6 million during the three months ended September 30, 2019 compared with $6.0 million during the three months ended September 30, 2018. The decrease of $1.4 million is primarily due to a decrease in legal and related costs associated with various matters, including litigation activities, related to the departure of certain executives and directors during 2018, partially offset by increases in insurance premiums.

    Research and product development expenses were $1.5 million for the three months ended September 30, 2019 compared with $0.8 million during the three months ended September 30, 2018. The increase was due to the Company's commitment to investing in and building the medical capabilities mentioned above, including generating data from studies and real-world use of Triferic to support medical education and development efforts, as well as the expansion of the Company's internal medical affairs staff. The Company expects its research and product development expenses to increase in the future due to additional clinical development of Dialysate and I.V. Triferic, including the pediatric clinical trial for Triferic, expenses associated with real-world data collection and analysis for Triferic, and an increase in headcount to support medical education efforts for Triferic.  

    Other income for the three months ended September 30, 2019 was $0.1 million, consisting primarily of interest income. Other income for the three months ended September 30, 2018 was approximately $29,000, consisting of $0.13 million of interest income, offset by $0.1 million of realized gains on investments.

    The Company encourages shareholders to also review its Form 10-Q for the quarter ended September 30, 2019, as filed by the Company with the United States Securities and Exchange Commission ("SEC").

    Conference Call

    As previously announced, Rockwell Medical management will host its third quarter 2019 conference call as follows:

    Date Monday, November 11, 2019
    Time 4:30 PM EST
    Telephone   U.S:   (877) 383-7438
        International:   (678) 894-3975
    Webcast (live and archive) https://edge.media-server.com/mmc/p/kxajr6w6
       

    About Rockwell Medical
    Rockwell Medical is a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD). Rockwell Medical's exclusive renal drug therapy, Triferic, supports disease management initiatives to improve the quality of life and care of dialysis patients and is intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. The Company has developed multiple formulations of Triferic: (1) Dialysate Triferic; and (2) I.V. Triferic. Dialysate Triferic is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. The Company's strategy is to bring its therapeutics to market in the United States and to utilize partners to develop and commercialize such therapeutics in international markets. 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. Please visit www.rockwellmed.com for more information.

    About Triferic
    Triferic is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment. Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Unlike traditional IV iron products, 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. 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 with a PDUFA date of March 28, 2020. Please visit www.triferic.com to view the Triferic mode-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    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 bring to market Triferic, and I.V. Triferic. 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: statements about the issuance of a unique J code for our Triferic Powder Packet; timing and regulatory approval process for Dialysate Triferic in China; timing and regulatory approval process of our NDA filing for I.V. Triferic as filed with the FDA;  the potential market opportunity and commercialization of Dialysate Triferic in China; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; pricing and reimbursement status for I.V. Triferic and other Rockwell Medical products, CMS' recently announced final rule regarding eligibility for TDAPA; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; the progress and success with regard to our recently announced commercialization of Dialysate Triferic; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    Financial Tables Follow

     
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED BALANCE SHEETS
        September 30,   December 31,
        2019   2018
          (Unaudited)      
    ASSETS            
    Cash and Cash Equivalents   $ 14,421,394     $ 22,713,980  
    Investments Available-for -Sale     14,575,589       10,818,059  
    Accounts Receivable, net     5,122,453       6,979,514  
    Insurance Receivable           371,217  
    Inventory     3,583,452       4,038,778  
    Prepaid and Other Current Assets     2,861,708       1,903,682  
    Total Current Assets     40,564,596       46,825,230  
    Property and Equipment, net     2,506,093       2,638,293  
    Inventory, Non-Current     528,000       1,637,000  
    Right of Use Assets, net     3,011,805        
    Goodwill     920,745       920,745  
    Other Non-current Assets     555,933       536,516  
    Total Assets   $ 48,087,172     $ 52,557,784  
    LIABILITIES AND SHAREHOLDERS' EQUITY            
    Accounts Payable   $ 3,194,039     $ 4,492,071  
    Accrued Liabilities     3,916,069       5,129,761  
    Settlement Payable     270,000       416,668  
    Lease Liability - Current     1,482,441        
    Deferred License Revenue - Current     2,238,450       2,252,868  
    Insurance Financing Note Payable     1,145,133        
    Customer Deposits     48,163       63,143  
    Other Current Liability - Related Party     100,000       850,000  
    Total Current Liabilities     12,394,295       13,204,511  
                 
    Lease Liability - Long-Term     1,589,098        
    Deferred License Revenue - Long-Term     10,401,166       12,076,399  
    Total Liabilities     24,384,559       25,280,910  
                 
    Shareholders' Equity:            
    Preferred Shares, $.0001 par value, no shares issued and outstanding at September 30, 2019
    and December 31, 2018
               
    Common Shares, $.0001 par value; 170,000,000 shares authorized; 63,887,384 and 57,034,154
    shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively
        6,389       5,703  
    Additional paid-in capital     322,837,353       299,596,257  
    Accumulated Deficit     (299,213,836 )     (272,388,234 )
    Accumulated Other Comprehensive Income     72,707       63,148  
    Total Shareholders' Equity     23,702,613       27,276,874  
    Total Liabilities And Shareholders' Equity   $ 48,087,172     $ 52,557,784  
                 



                             
    ROCKWELL MEDICAL, INC. AND SUBSIDIARIES
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
                             
    (Unaudited)
                             
        Three Months Ended
    September 30, 2019
      Three Months Ended
    September 30, 2018
      Nine Months Ended
    September 30, 2019
      Nine Months Ended
    September 30, 2018
                             
    Net Sales   $ 15,407,248     $ 16,672,416     $ 45,812,475     $ 46,534,358  
    Cost of Sales     15,423,612       14,703,606       44,085,298       49,303,048  
    Gross Profit (Loss)     (16,364 )     1,968,810       1,727,177       (2,768,690 )
    Selling and Marketing     1,827,473       121,874       7,148,848       716,414  
    General and Administrative     4,623,503       6,037,267       16,340,672       14,465,634  
    Settlement Expense                 430,000       1,030,000  
    Research and Product Development     1,474,735       808,192       4,930,287       4,033,494  
    Operating Loss     (7,942,075 )     (4,998,523 )     (27,122,630 )     (23,014,232 )
                             
    Other Income                        
    Realized Gain (Loss) on Investments     6,268       (97,027 )     24,292       (222,014 )
    Interest Income, net     80,735       125,918       272,736       486,301  
    Total Other Income     87,003       28,891       297,028       264,287  
                             
    Net Loss   $ (7,855,072 )   $ (4,969,632 )   $ (26,825,602 )   $ (22,749,945 )
                             
                             
    Basic and Diluted Net Loss per Share   $ (0.12 )   $ (0.10 )   $ (0.45 )   $ (0.44 )
                             
    Basic and Diluted Weighted Average Shares
    Outstanding
        63,796,723       51,288,537       59,728,446       51,288,462  
                             


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  39. WIXOM, Mich., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD), today announced that the Company will sponsor a Triferic (ferric pyrophosphate citrate) Exhibitor Spotlight presentation at the American Society of Nephrology (ASN) Kidney Week 2019 Conference in Washington, D.C. on Friday, November 8, 2019.

    Presentation Title:   Advances in Hemodialysis-Associated Anemia Management: The Benefits of Physiologic Iron Replacement Therapy
         
    Presenter:   Jay B. Wish, MD, Professor of Clinical Medicine, Chief Medical Officer for Dialysis, Indiana

    WIXOM, Mich., Nov. 07, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI) ("Rockwell Medical" or the "Company"), a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD), today announced that the Company will sponsor a Triferic (ferric pyrophosphate citrate) Exhibitor Spotlight presentation at the American Society of Nephrology (ASN) Kidney Week 2019 Conference in Washington, D.C. on Friday, November 8, 2019.

    Presentation Title:   Advances in Hemodialysis-Associated Anemia Management: The Benefits of Physiologic Iron Replacement Therapy
         
    Presenter:   Jay B. Wish, MD, Professor of Clinical Medicine, Chief Medical Officer for Dialysis, Indiana University Health
         
    Date:   Friday, November 8, 2019
         
    Time:   10:00 am – 11:00 am
         
    Location:   Walter E. Washington Convention Center, Exhibit Hall, Theater #1, Washington, D.C.

    In today's clinical practice, it is very common to use traditional intravenous (IV) iron for repeated replacement of ongoing iron losses in chronic hemodialysis patients. This practice results in increased iron stores together with systemic inflammation.1 The long-range safety of such regular weekly or monthly traditional intravenous iron dosing regimens is a subject of some concern and controversy.2 Adverse effects of traditional intravenous iron may be concealed by their resemblance to common comorbidities in dialysis patients, such as infection, cardiovascular disease, and early mortality.3 Evidence of the negative effects of iron overload and other risks associated with long-term use of intravenous iron continues to build.3

    Unlike traditional IV iron, Triferic replaces dialysis patients' ongoing iron losses by providing iron with every hemodialysis treatment that is 100% bioavailable and maintains hemoglobin without increasing iron stores (ferritin). Triferic has a safety profile similar to placebo, with few Triferic-related serious adverse events reported in over 1,000,000 patient administrations.4,5

    "We are very excited to have a clinician of Dr. Wish's distinction and expertise speak on behalf of Triferic and believe this will be an extremely valuable presentation for all nephrologists who deal with issues around anemia management. Educating the medical community about the profile of Triferic through engagement with esteemed medical leaders is critical to get this important therapeutic to more patients," said Stuart Paul, President and Chief Executive Officer of Rockwell Medical.

    About Triferic
    Triferic is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment. Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Unlike traditional IV iron products, 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. 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 with a PDUFA date of March 28, 2020. Please visit www.TRIFERIC.com to view the Triferic mode-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.TRIFERIC.com.

    About Rockwell Medical
    Rockwell Medical is a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical's exclusive renal drug therapy, Triferic, supports disease management initiatives to improve the quality of life and care of dialysis patients and is intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. The Company has developed multiple formulations Triferic: (1) Dialysate Triferic; and (2) I.V. Triferic. Dialysate Triferic is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. The Company's strategy is to bring its therapeutics to market in the United States and to utilize partners to develop and commercialize such therapeutics in international markets. 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. Please visit www.rockwellmed.com for more information.

    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 bring to market Triferic, and I.V. Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "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: statements about the timing of data readouts; the timing for the ruling from CMS; potential market opportunity for I.V. Triferic, as well as other Rockwell Medical products; pricing and reimbursement status for I.V. Triferic and other Rockwell Medical products, including the eligibility of I.V. Triferic for add-on reimbursement under TDAPA; liquidity and capital resources; expected duration of Rockwell Medical's existing working capital; success of our recently announced commercialization of Dialysate Triferic; and timing and success of our efforts to maintain, grow and improve the profit margin of the Company's concentrate business. 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:

    Source: Rockwell Medical, Inc.

    ________________________

    1. Monitor DP: DOPPS 6. In, 2019
    2. Macdougall IC, White C, Anker SD, et al. Intravenous Iron in Patients Undergoing Maintenance Hemodialysis. The New England Journal of Medicine 2019; 380: 447-458.
    3. Kalantar-Zadeh K, Regidor DL, McAllister CJ, Michael B, Warnock DG. Time-dependent associations between iron and mortality in hemodialysis patients. J Am Soc Nephrol. 2005;16(10):3070-3080
    4. Fishbane SN, Singh AK, Cournoyer SH,et al. Ferric pyrophosphate citrate (Triferic®)  administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant. 2015;30(12):2019-2026.
    5. Data on file. Wixom, MI; Rockwell Medical, Inc.

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  40. WIXOM, Mich., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. ("Rockwell Medical" or the "Company") (NASDAQ:RMTI) today announced that the Company will release its 2019 third quarter financial results on Monday, November 11, 2019, after the close of the U.S. financial markets.

    Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Monday, November 11, 2019 
    Time 4:30 p.m. EST
    Toll free (U.S.) (877) 383-7438
    International (678) 894-3975
    Webcast (live and replay)  www.rockwellmed.com under the "Investor" section

    The webcast will be archived for 30 days at the aforementioned URL.

    About Triferic
    Triferic is the only FDA-approved therapy indicated…

    WIXOM, Mich., Nov. 04, 2019 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. ("Rockwell Medical" or the "Company") (NASDAQ:RMTI) today announced that the Company will release its 2019 third quarter financial results on Monday, November 11, 2019, after the close of the U.S. financial markets.

    Stuart Paul, Chief Executive Officer, and Angus Smith, Chief Financial Officer, will host a conference call to discuss the results as follows:

    Date Monday, November 11, 2019 
    Time 4:30 p.m. EST
    Toll free (U.S.) (877) 383-7438
    International (678) 894-3975
    Webcast (live and replay)  www.rockwellmed.com under the "Investor" section

    The webcast will be archived for 30 days at the aforementioned URL.

    About Triferic
    Triferic is the only FDA-approved therapy indicated to replace iron and maintain hemoglobin in hemodialysis patients via dialysate during each dialysis treatment. Triferic delivers approximately 5-7 mg iron with every hemodialysis treatment to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Unlike traditional IV iron products, 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. 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 with a PDUFA date of March 28, 2020. Please visit www.triferic.com to view the Triferic mode-of-action (MOA) video and for more information.

    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%).

    For more information, including full prescribing information, visit: http://www.triferic.com.

    About Rockwell Medical
    Rockwell Medical is a biopharmaceutical company dedicated to improving outcomes for patients with anemia, with an initial focus on end-stage renal disease (ESRD) and chronic kidney disease (CKD). Rockwell Medical's exclusive renal drug therapy, Triferic, supports disease management initiatives to improve the quality of life and care of dialysis patients and is intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. The Company has developed multiple formulations of Triferic: (1) Dialysate Triferic; and (2) I.V. Triferic. Dialysate Triferic is the only FDA-approved therapeutic indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. The Company's strategy is to bring its therapeutics to market in the United States and to utilize partners to develop and commercialize such therapeutics in international markets. 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. Please visit www.rockwellmed.com for more information.

    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 bring to market Triferic, and I.V. Triferic. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "could," "plan,&#