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Precigen Reports Third Quarter 2023 Financial Results and Progress of Clinical Programs
– Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in RRP will serve as the pivotal study to support BLA
About this update from Precigen, Inc.
[{"type":"text","content":"– Based on FDA confirmation in August 2023 that the ongoing Phase 1/2 single-arm study of PRGN-2012 in RRP will serve as the pivotal study to support BLA submission under an accelerated approval request, the Company has expedited efforts to attain commercial readiness –\n– Full results of the Phase 1 portion of the ongoing Phase 1/2 study of PRGN-2012 were published in the peer-reviewed journal, Science Translational Medicine, and presented in an oral presentation at the ESGCT 30th Annual Congress –\n– Enrollment and dosing was completed in the Phase 2 study of PRGN-2012 in RRP; Phase 2 study completion expected in the second quarter of 2024 –\n– Cash, cash equivalents, short-term and long-term investments totaled $79.0 million as of September 30, 2023; cash runway projected into 2025 –\n– Continued focus on cost containment resulted in a reduction in SG&A costs of 17% for the nine months ended September 30, 2023, compared to the prior year over the same period –\nGERMANTOWN, Md., Nov. 9, 2023 /PRNewswire/ -- Precigen, Inc. (Nasdaq: PGEN), a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today announced third quarter 2023 financial results and progress of clinical programs.\n\n \n \n \n \n \n \n\n \n\"Precigen has made tremendous progress in reducing our operating costs and we are actively reprioritizing our programs to enable commercial readiness for our lead asset, PRGN-2012. We anticipate completing the PRGN-2012 Phase 2 study in the second quarter of 2024 and, given the FDA's guidance in August 2023 that the ongoing Phase 1/2 study of PRGN-2012 will serve as the pivotal study to support an accelerated approval request, we are working to expedite the submission of a BLA as quickly as possible,\" said Helen Sabzevari, PhD, President and CEO of Precigen. \"We have recently published exciting new data for both of the Company's core platforms, AdenoVerse and UltraCAR-T, including presentations at the ESGCT 30th Annual Congress for PRGN-3007 UltraCAR-T and PRGN-2012 AdenoVerse immunotherapy, and publication of a manuscript in Science Translational Medicine that includes full Phase 1 data from the PRGN-2012 clinical study. Each publication builds the body of clinical evidence for the potential of our innovative therapeutic platforms in meeting unmet ...