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Rani Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results; Provides Corporate Update
- Anticipates initiating first Phase 2 clinical study in RT-102 in 2H of 2023 - - Announced topline results from the Phase 1 repeat-dose study of RT-102 for
About this update from Rani Therapeutics Holdings, Inc.
[{"type":"text","content":"- Anticipates initiating first Phase 2 clinical study in RT-102 in 2H of 2023 - - Announced topline results from the Phase 1 repeat-dose study of RT-102 for the treatment of osteoporosis - - Received preliminary feedback from FDA on RT-102 development plans; 505(b)(2) pathway for RT-102 could be suitable - - Announced partnership with Celltrion on development of RT-111, a RaniPill GO capsule containing an ustekinumab biosimilar - - Conference call and webcast today at 4:30 p.m. ET - SAN JOSE, Calif., March 22, 2023 (GLOBE NEWSWIRE) -- Rani Therapeutics Holdings, Inc. (“Rani Therapeutics” or “Rani”) (Nasdaq: RANI), a clinical-stage biotherapeutics company focused on the oral delivery of biologics and drugs, today reported financial results for the quarter and full year ended December 31, 2022 and provided a corporate update. “The past year has proven transformative for Rani, highlighted by the positive topline Phase 1 results for RT-102 in osteoporosis and the unveiling of our high-capacity capsule, the RaniPill HC. We also announced the preclinical development of our oral ustekinumab program, RT-111, and earlier this year partnered with Celltrion to support the advancement of that program. These achievements mark significant milestones for the Company and are a testament to the hard work and dedication of the entire Rani team,” said Talat Imran, Chief Executive Officer of Rani. “In 2023, we anticipate continuing this momentum with the initiation of the Company’s first Phase 2 study in RT-102 as well as the initiation of Phase 1 studies with three additional pipeline assets. I look forward to providing updates throughout the year as we work to further solidify our commitment to developing orally delivered biologics and drugs.” Fourth Quarter 2022 and Subsequent Highlights: Announced topline results from Phase 1 study of RT-102. In December 2022, Rani announced topline results from Part 2 (repeat-dose portion) of the Phase 1 study of RT-102. RT-102 is being developed for the treatment of osteoporosis. The study achieved all of its endpoints, with repeat doses of RT-102 being generally well tolerated and delivering drug with high reliability to participants via the RaniPill GO.Preliminary feedback received from the U.S. Food and Drug Administration (“FDA”) on future development of RT-102. Following feedback from a pre-IND meeting w...