RMTI Rockwell Medical Inc.

1.07
-0.03  -3%
Previous Close 1.1
Open 1.11
52 Week Low 1.02
52 Week High 3.85
Market Cap $75,218,661
Shares 70,297,814
Float 57,744,773
Enterprise Value $58,574,051
Volume 3,201,618
Av. Daily Volume 1,860,587
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Drug Pipeline

Drug Stage Notes
IV Triferic
Anemia
Approved
Approved
FDA approval announced date March 27, 2020.
Soluble Ferric Pyrophosphate
Anemia
Approved
Approved
Approved January 26, 2015.

Latest News

  1. -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
  2. 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
  3. 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

    View Full Article Hide Full Article
  4. 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

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  5. 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

     

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