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Unicycive Therapeutics Announces Third Quarter 2021 Financial Results
Expect to receive confirmatory guidance on Renazorb regulatory pathway from the U.S. Food and Drug Administration in Q4 2021 LOS ALTOS, Calif., Nov. 11, 2021
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Expect to receive confirmatory guidance on Renazorb regulatory pathway from the U.S. Food and Drug Administration in Q4 2021\n\n\nLOS ALTOS, Calif., Nov. 11, 2021 /PRNewswire/ -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today reported financial results for the third quarter ended September 30, 2021. \n\n \n \n \n \n \n \n\n \nShalabh Gupta, M.D., Chief Executive Officer, stated, \"With our addition to the Russell Microcap Index and conference participation, we made meaningful corporate progress to expand the interest and visibility of Unicycive within the investment community last quarter. We are also pleased to have biopharmaceutical executive Douglas Jermasek on our team whose broad experience working with kidney disease treatments has already made a huge impact.\"\n\"In chronic kidney disease (CKD), hyperphosphatemia is caused by a chronic dysregulation of phosphates and occurs in at least 70% of patients with Stage 5 CKD. Current treatments for hyperphosphatemia come with a very high pill burden that can result in poor patient adherence. Our lead program, Renazorb, combines one of the most potent phosphate lowering agents with a smaller, easier swallowed pill to potentially improve the treatment outcomes for patients. We are working with the U.S. Food and Drug Administration (FDA) on our regulatory pathway for Renazorb and expect to receive confirmatory guidance in Q4 2021,\" added Dr. Gupta.\nKey Highlights and Upcoming Milestones\nBiopharmaceutical executive Douglas Jermasek appointed as Executive Vice President, Corporate Strategy Unicycive added to the Russell Microcap Index as part of the 2021 Russell indexes reconstitution Presented at H.C. Wainwright 23rd Annual Global Investment Conference Upcoming presentation at the Benchmark Discovery One on One Investor Conference Expect to receive confirmatory guidance on Renazorb regulatory pathway from the FDA in Q4 2021 Planned completion of pre-clinical studies with UNI-494 in the first half of 2022Third Quarter 2021 Financial Results\nResearch and development expenses for the third quarter of 2021 were $3.8 million, compared to $0.3 million for the third quarter of 2020. This increase was primarily attributable to a one-time $2.2 million increase in non-cash expense from the is...