Business
Precision BioSciences Reports Fourth Quarter and Fiscal Year 2023 Financial Results and Provides Business Update
- Initiated final IND/CTA enabling studies for lead in vivo gene editing program PBGENE-HBV; expect to submit IND and/or CTA in 2024 - Completed licensing
About this update from Precision Biosciences, Inc.
[{"type":"text","content":"\n- Initiated final IND/CTA enabling studies for lead in vivo gene editing program PBGENE-HBV; expect to submit IND and/or CTA in 2024\n\n\n- Completed licensing agreements to monetize divested CAR T assets with Imugene, TG Therapeutics and Caribou Biosciences including nearly $50 million in upfront and potential near-term payments\n\n\n- Completed $40 million in public offering extending our anticipated cash runway into the second half of 2026 which is expected to enable achievement of first-in-human Phase 1 clinical data for two wholly owned programs - Hepatitis B & Primary Mitochondrial Myopathy\n\n\n DURHAM, N.C.--(BUSINESS WIRE)--\nPrecision BioSciences, Inc. (Nasdaq: DTIL), an advanced gene editing company utilizing its novel proprietary ARCUS® platform to develop in vivo gene editing therapies for sophisticated gene edits, including gene elimination, insertion, and excision, today announced financial results for the fourth quarter and fiscal year ended December 31, 2023 and provided a business update.\n\n\n“2023 was a transformative year for Precision BioSciences as we fully transitioned to our core capability as an in vivo gene editing company rapidly advancing development of our wholly owned in vivo programs led by PBGENE-HBV and quickly followed by PBGENE-PMM. As a part of this transition, we successfully monetized our prior CAR T investments and completed a $40 million public offering, strengthening our balance sheet beyond Phase 1 readouts for both wholly owned programs,” said Michael Amoroso, President and Chief Executive Officer of Precision BioSciences. “We are well positioned to continue to execute against our objectives, having received regulatory feedback from the U.S. Food and Drug Administration (FDA) and key regulatory agencies outside the U.S. which provided clarity and alignment to guide our planned investigational new drug (IND) and/or clinical trial application (CTA) filings for PBGENE-HBV in 2024. In addition, our partner iECURE has advanced the first ARCUS-mediated gene editing program into the clinic, bolstering our confidence and establishing regulatory precedent for ARCUS in vivo gene editing programs with the potential to deliver a curative treatment for patients.”\n\n\n“As we look ahead, we continue to advance our focused strategy to differentiate ARCUS within the gene editing field and progress b...