RMTI Rockwell Medical Inc.

1.92
-0.01  -1%
Previous Close 1.93
Open 1.91
52 Week Low 1.306
52 Week High 3.85
Market Cap $132,267,284
Shares 69,069,078
Float 56,516,037
Enterprise Value $108,232,890
Volume 230,178
Av. Daily Volume 594,197
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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

    • 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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  1. 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

    d

    Primary Logo

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  2. 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
     

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  3. -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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  4. 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:
    David Rosen
    Argot Partners
    212.600.1902

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