Business
Unicycive Announces First Quarter 2023 Financial Results and Provides Business Update
Closed on previously announced transformational fundraising that included $30 million financing upfront with up to an additional $100 million tied to the
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Closed on previously announced transformational fundraising that included $30 million financing upfront with up to an additional $100 million tied to the satisfaction of milestones Continued progress with plan to file New Drug Application with the U.S. Food and Drug Administration in Q3 2023, with the potential for approval and launch in 2024 LOS ALTOS, Calif., May 16, 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 first quarter ended March 31, 2023 and provided a business update. “The first quarter of 2023 was transformational for Unicycive and positions us for continued success throughout the balance of the year and beyond as we expect to file our New Drug Application (NDA) for Renazorb™ in the third quarter of 2023 and, if approved, plan for its potential commercial launch in 2024, which should provide additional funding in connection with our recent financing agreement,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Additionally, we continue to expand our scientific and clinical body of evidence for both of our product candidates’ potential to transform the treatment of acute and chronic kidney disease. The Unicycive team has presented data from studies of Renazorb and UNI-494 at key renal medical meetings worldwide. We will continue to share data demonstrating the potential of our lead programs in kidney disease before audiences of the world’s leading nephrologists and believe it may enhance our commercial launch efforts for Renazorb and our development efforts as we advance our global clinical trials for UNI-494,” concluded Dr. Gupta. Key Highlights of the First Quarter and Recent Months In February 2023, Unicycive entered into an exclusive license agreement with Lotus Pharmaceutical (“Lotus”, Taiwan TWSE ticker: 1795), a leading global pharmaceutical company, for the development and commercialization of Renazorb (lanthanum dioxycarbonate) in the Republic of Korea.In early March 2023, the Company signed a securities purchase agreement with certain healthcare-focused institutional investors that provides for up to $130 million in gross proceeds through a private placement that included initial upfront funding of $3...