Business
Unicycive Announces Full Year 2022 Financial Results and Provides Business Update
Closed transformational fundraise that included $30 million financing upfront with up to an additional $100 million tied to satisfaction of milestones
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Closed transformational fundraise that included $30 million financing upfront with up to an additional $100 million tied to satisfaction of milestones Financing by new and existing institutional investors from high-profile healthcare-focused funds to support launch and commercialization of investigational new drug, Renazorb™ Company on track to file New Drug Application with the U.S. Food and Drug Administration in mid-2023 with potential for approval and launch in 2024 LOS ALTOS, Calif., March 31, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2022 and provided a business update. “Our recent financing, combined with the successful, pivotal bioequivalence (BE) study for Renazorb™, is transformational for Unicycive as they support Renazorb’s best-in-class potential as a treatment for hyperphosphatemia and provide funding for its commercial launch, if approved,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Importantly, we are on track to file a New Drug Application (NDA) for Renazorb marketing approval with the U.S. Food and Drug Administration (FDA) in mid-year, which should provide additional funding in connection with our recent financing agreement upon approval.” “We continue to make progress with our plans for the commercialization of Renazorb for the treatment of hyperphosphatemia, where our strengthened balance sheet provides the resources needed to drive increased market awareness of Renazorb’s potential best-in-class product profile and to plan and execute our go-to-market strategy to bring this novel treatment to patients. If approved, Renazorb may dramatically reduce the pill burden that patients endure with currently available medications. “The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines. The timing of Renazorb’s expected launch coincides favorably with the p...