Precision BioSciences, Inc. - DTIL STOCK NEWS

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.

iECURE has completed a $65 million Series A-1 financing round, co-led by Novo Holdings and LYFE Capital, raising its total funding to $115 million. This capital will support pre-IND activities and clinical trial initiation for its lead product targeting Ornithine Transcarbamylase (OTC) deficiency, alongside efforts for Citrullinemia Type 1. Key appointments to the Board of Directors were made, including members from Novo Ventures and LYFE Capital. The company aims to develop mutation-agnostic gene therapies for liver disorders with high unmet medical needs.

Precision BioSciences, Inc. (DTIL) announced that Dr. Raymond Schinazi has stepped down from its Board of Directors, effective November 5, 2022. He will continue to contribute as a member of the Scientific Advisory Board. His tenure on the board began in early 2019, during which he provided valuable insights into the company's CAR T and gene editing pipeline. The company is focused on developing innovative therapies for unmet medical needs, including a potential cure for chronic hepatitis B, leveraging its proprietary ARCUS genome editing platform.

Precision BioSciences reported Q3 2022 results, revealing revenues of $7.4 million, a significant drop from $24 million in Q3 2021, mainly due to the absence of previous revenue linked to the iECURE Agreement. The company's net loss widened to $23.9 million, or $(0.22) per share, up from $11.3 million, with diluted shares increasing to about 110.8 million. Positive highlights include a strong cash position of $212.1 million expected to fund operations through 2024 and advancements in CAR T programs aimed at treating relapsed non-Hodgkin lymphoma. Updates on clinical trials are anticipated in late Q4 2022 or early Q1 2023.

On November 2, 2022, Precision BioSciences (DTIL) announced the approval of inducement awards for 15 new employees, comprising stock options for 272,352 shares at an exercise price of $1.39. The options are part of the 2021 Employment Inducement Incentive Award Plan, and will vest over four years. Precision BioSciences focuses on developing ARCUS-based gene editing therapies, aimed at treating genetic and infectious diseases.

Precision BioSciences (Nasdaq: DTIL) announced an accepted abstract for poster presentation at the 64th American Society of Hematology Annual Meeting in New Orleans from December 10-13, 2022. The poster will detail the effective cell dose and functional attributes of its lead CD19 candidate, Azercabtagene Zapreleucel (azer-cel), in treating relapsed or refractory non-Hodgkin lymphoma. This analysis highlights the product's composition and cell doses, which may improve safety and efficacy. Dr. Alan List emphasized the significance of maximizing naïve cell phenotype in allogeneic CAR T therapy.

Precision BioSciences, Inc. (Nasdaq: DTIL) has announced plans to publish its financial results for the third quarter of 2022 on November 8, 2022, along with a business update. The company focuses on developing ex vivo allogeneic CAR T and in vivo gene editing therapies using its proprietary ARCUS® genome editing platform. This platform is designed for therapeutic safety and versatility and aims to address genetic and infectious diseases lacking effective treatments.

Precision BioSciences (Nasdaq: DTIL) announced an inducement grant for Michael Amoroso, its CEO, under the 2021 Employment Inducement Incentive Award Plan. This grant includes an option to purchase 250,000 shares at a price of $1.38, with 25% vesting on October 15, 2023, and the remainder vesting over three years. The grant complies with Nasdaq Listing Rules as material to Mr. Amoroso's employment. Precision BioSciences specializes in gene editing therapies using its proprietary ARCUS® platform, targeting genetic and infectious diseases.