Business
Rockwell Medical Provides Corporate and Clinical Update
- Closes $7.5 Million Second Tranche Investment from DaVita - $30 Million in Total Capital Raised This Quarter - Receives Additional Feedback from FDA on its
About this update from Rockwell Medical, Inc.
[{"type":"text","content":"- Closes $7.5 Million Second Tranche Investment from DaVita\n- $30 Million in Total Capital Raised This Quarter\n- Receives Additional Feedback from FDA on its IND Application\nWIXOM, Mich., June 22, 2022 /PRNewswire/ -- Rockwell Medical, Inc. (Nasdaq: RMTI), a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients, today provided an update on its recent capital raise and a clinical update on safety enhancements to its planned Phase 2 clinical trial of Ferric Pyrophosphate Citrate (FPC) in home infusion patients.\n\n \n \n \n \n \n \n\n \nOn June 16, 2022 Rockwell Medical closed the second $7.5 million tranche of the previously announced DaVita, Inc (NYSE:DVA) stock purchase agreement under which DaVita agreed to purchase up to $15 million in convertible preferred stock in two tranches. This investment, in addition to the recently announced $15 million financing, brings the total gross amount raised by Rockwell this quarter to $30 million. There were no commissions paid on either investment.\n\"This capital, when combined with the initiatives we completed earlier this year, will extend our cash runway meaningfully, during which time we will continue advancing our Ferric Pyrophosphate Citrate (FPC) development programs and improving our dialysis business,\" said Russell Skibsted, Executive Vice President, CFO and CBO. \"We plan to restructure and grow our dialysis business to generate improved gross margins and cash flow. On the development side, with the rapidly growing trend toward medical care at home, we are preparing to conduct our Phase 2 clinical trial of FPC in home infusion patients, a population with a significant unmet burden from iron deficiency anemia, pending submission of additional CMC microbial data in support of FDA clearance to begin this trial.\" \nDue to the fact that the eventual commercial presentation of FPC) for the treatment of iron deficiency anemia and maintenance of hemoglobin in patients receiving infusion therapy in the home setting, a single dose sterile unit, is still in development, the planned Phase 2 proof of concept study design requires that three units of the existing FDA-approved IV product be compounded into a single unit for each patient dose. Because of this necessary step, the U.S. Food and Drug Admi...