Rockwell Medical, Inc., a biopharmaceutical company dedicated to transforming the treatment of iron deficiency and anemia management and improving outcomes for patients, 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.
On June 16, 2022 Rockwell Medical closed the second $7.5 million tranche of the previously announced DaVita, Inc 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.
“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.”
Due 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 Administration (FDA) requested that Rockwell perform a microbial challenge study, a standard study testing the potential for microbial growth. Successful completion of this study will add an additional layer of safety for clinical trial patients.
“We are pleased to provide the FDA with the additional data requested and fully support the generation of any data that will further assure the safety of the patients that will participate in our study,” said Marc Hoffman, M.D., Chief Medical Officer of Rockwell Medical. “We continue to make progress toward clearance of our IND. We believe the requested microbial challenge study will have minimal impact on our proposed Phase 2 program timeline or cost as the tests will be conducted in parallel with the clinical study start-up activities.”