Precision BioSciences, Inc. - DTIL STOCK NEWS

iECURE, a gene editing company, announced that the European Commission has granted orphan designation for its lead product, GTP-506, aimed at treating Ornithine Transcarbamylase (OTC) deficiency. This follows similar designations from the U.S. FDA. The orphan designation signifies that this treatment addresses a significant unmet medical need for a rare condition affecting fewer than 5 in 10,000 people in the EU. GTP-506 employs a novel gene editing approach, offering the potential for long-term therapeutic benefits. The company collaborates with the University of Pennsylvania to advance its therapies.

Precision BioSciences (Nasdaq: DTIL) reported Q4 and fiscal year 2022 results with revenues of $10.6 million for Q4, up from $6.3 million year-over-year, and $25.1 million for the fiscal year, down from $115.5 million in 2021. Key advancements include clinical progress in CAR T therapies azer-cel and PBCAR19B, with FDA engagement ongoing. Net loss for Q4 was $28.5 million, or $(0.26) per share, while the annual net loss was $111.6 million, or $(1.27) per share. The company maintains a strong cash position of $189.6 million, projected to fund operations through Q1 2025. Notable clinical updates and collaborations with partners like Novartis and Lilly are anticipated in 2023.

Precision BioSciences, Inc. (NASDAQ: DTIL) announced plans to release its financial results for Q4 and the fiscal year 2022 on March 9, 2023. The company is focused on gene editing through its proprietary ARCUS® platform, aiming to develop allogeneic CAR T and in vivo therapies to treat genetic and infectious diseases. With its innovative approach, Precision is committed to advancing treatments where no adequate solutions currently exist.

Precision BioSciences, Inc. (Nasdaq: DTIL) has announced key leadership changes. Neil Leatherbury is promoted to Senior Vice President, Head of Chemistry, Manufacturing, and Controls (CMC), taking over from Derek Jantz, Ph.D., who transitions to an advisory role as Co-Founder and Chief Science Advisor. Jantz will continue to support business relationships and executive guidance. Jeff Smith, Ph.D., remains Chief Research Officer, leading research strategies, including collaborations with Lilly and Novartis. These changes aim to enhance the company's position in gene editing and CAR T therapy development as they move towards commercialization.

Precision BioSciences, Inc. (Nasdaq: DTIL), a clinical-stage gene editing company, will participate in the H.C. Wainwright Cell Therapy Virtual Conference on February 28, 2023. The event will feature a virtual fireside chat at 2:00 PM ET, accessible via a live webcast on the company's website. An archived replay will be available for 30 days post-event. Precision BioSciences focuses on developing ex vivo allogeneic CAR T and in vivo gene editing therapies using its proprietary ARCUS® platform, aiming to treat genetic and infectious diseases with no adequate treatments. For details, visit website.

Precision BioSciences (Nasdaq: DTIL) announced on February 9, 2023, that its Compensation Committee approved grants of inducement awards to eight new employees under the 2021 Employment Inducement Incentive Award Plan. The awards consist of stock options for a total of 159,097 shares with an exercise price of $1.13 per share. Each option has a 10-year term and vests 25% after one year, with the remaining 75% vesting quarterly over three years. This plan aims to attract and retain talent in the competitive biotechnology sector as Precision advances its ARCUS® genome editing platform and related therapies.

Precision BioSciences (DTIL) reported substantial achievements in 2022, including a collaboration with Novartis for gene editing in sickle cell disease, and bolstering its cash reserves by $125 million. The company highlighted a 100% response rate in its Phase 1b study of azer-cel and outlined significant goals for 2023, including advancing azer-cel towards a Phase 2 trial and submitting an IND application for its HBV program by 2024. The firm expects $190 million in cash equivalents as of December 31, 2022, sufficient for operations until 2025.

Precision BioSciences (DTIL) has received supportive feedback from the FDA regarding its CMC processes for the allogeneic CAR T therapy azer-cel, aimed at treating relapsed or refractory non-Hodgkin lymphoma. This marks a crucial developmental step as the company aligns its processes with regulatory expectations. The FDA's insights pertain to analytical methods and manufacturing processes that are essential for azer-cel’s ongoing trials. The firm envisions azer-cel becoming the first marketed allogeneic CAR T therapy, addressing a significant patient need.

Precision BioSciences (NASDAQ: DTIL) presented data on its allogeneic CAR T candidate, Azercabtagene Zapreleucel (azer-cel), highlighting the significant relationship between CAR T cell composition, effective cell dose, and clinical outcomes. The analysis, showcased at the American Society of Hematology Annual Meeting, indicated that CAR T expansion correlates strongly with effective cell dose. The investigational product is currently undergoing Phase 1/2a trials for patients with relapsed/refractory B-cell lymphoma.