Business
Precision BioSciences Reports Second Quarter 2023 Financial Results and Provides Business Update
- FDA Advice Provides Clarity on Future Development for Lead CAR T Program Candidate Azer-Cel; CAR T Partnering Discussions Ongoing - Presented Preclinical
About this update from Precision Biosciences, Inc.
[{"type":"text","content":"\n- FDA Advice Provides Clarity on Future Development for Lead CAR T Program Candidate Azer-Cel; CAR T Partnering Discussions Ongoing\n\n\n- Presented Preclinical Data Demonstrating Potential of ARCUS for Treatment of Duchenne Muscular Dystrophy and Chronic Hepatitis B\n\n\n- Company plans to host In Vivo Gene Editing R&D Day on September 12, 2023\n\n\n- Cash Balance Provides Expected Runway Through Q1 2025\n\n\n DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision BioSciences, Inc. (Nasdaq: DTIL), a clinical stage gene editing company developing ARCUS®-based in vivo gene editing and ex vivo allogeneic CAR T therapies, today announced financial results for the second quarter ended June 30, 2023 and provided a business update.\n\n\n“The first half of 2023 has been a busy time at Precision. Key updates have continued to elucidate the development and potential regulatory pathway for our ex vivo portfolio as well as demonstrate the potential of our proprietary ARCUS® genome editing platform as a differentiated technology for high efficiency in vivo gene insertion and excision,” said Michael Amoroso, Chief Executive Officer at Precision BioSciences. “Following our recent CAR T data update in May 2023 and subsequent Type B End of Phase 1 meeting with the U.S. Food and Drug Administration (FDA), we are actively engaging with potential partners to advance azer-cel and PBCAR19B to the next stage of development. As we prioritize organic development of our in vivo portfolio, we continue to generate supportive preclinical data to leverage the core features of ARCUS and advance differentiated programs to the clinic. We look forward to providing further updates across our in vivo programs at our upcoming gene editing R&D event in September.”\n\n\nEx Vivo Allogeneic CAR T Platform\n\n\nIn July 2023, Precision received final meeting minutes from its June 2023 Type B meeting with the FDA for azer-cel. The objective of the meeting was to gain further clarity on the potential registration path for azer‑cel including study design, endpoints, and the recommended phase 2 dose in the CAR T relapsed patient setting. The discussion with the FDA provided clarity on azer-cel development, including a potential pathway toward registration. Based on the advice received from the FDA and clinical data shared during the May 2023 CAR T update, Precision is currently advan...