Graphite Stock Price, News & Analysis

Graphite Bio, Inc. (Nasdaq: GRPH) announced its fourth quarter and fiscal year 2022 financial results, revealing a net loss of $24.6 million for Q4 and $101.1 million for the year. As of December 31, 2022, the company had cash and equivalents totaling $283.6 million. Significant updates include the discontinuation of the development of nula-cel for sickle cell disease and a voluntary pause of its Phase 1/2 CEDAR study due to serious adverse events. The company is undergoing a strategic review to evaluate alternatives while continuing research in its non-genotoxic conditioning program.

Graphite Bio, Inc. (NASDAQ: GRPH) announced the discontinuation of its nulabeglogene autogedtemcel (nula-cel) program for sickle cell disease following a thorough review of its business and resources. The decision stems from the challenges in resuming the CEDAR study and changes in the sickle cell treatment landscape. The company is exploring external development options for nula-cel while also focusing on its non-genotoxic conditioning program. Additionally, a corporate restructuring was approved, reducing the workforce by approximately 50% to decrease cash burn. As of December 31, 2022, Graphite Bio reported $283.5 million in cash and investments.

Graphite Bio (Nasdaq: GRPH) has voluntarily paused the Phase 1/2 CEDAR study of its gene therapy, nula-cel, for sickle cell disease following a serious adverse event involving prolonged low blood cell counts in the first patient. This decision impacts the company's timeline, as it will not meet its guidance for initial proof-of-concept data previously expected in mid-2023. The company is now assessing the risk factors and potential modifications to the manufacturing process of nula-cel. Additionally, it no longer anticipates filing for an investigational new drug application for another product by mid-2024.

Graphite Bio, Inc. (NASDAQ: GRPH) presented preclinical results at the ASH Annual Meeting indicating the efficacy of a single-cell RNA sequencing method to assess gene correction in sickle cell patients treated with nulabeglogene autogedtemcel (nula-cel). This investigational therapy aims to correct the mutation causing sickle cell disease (SCD). The research demonstrated the method's ability to measure and differentiate reticulocyte gene editing outcomes, providing crucial insights for nula-cel's clinical development.

Graphite Bio (Nasdaq: GRPH) reported significant progress in its clinical development and financial performance for Q3 2022. The company successfully dosed its first patient in the Phase 1/2 CEDAR trial for nula-cel, a gene editing therapy for sickle cell disease, with initial proof-of-concept data expected in mid-2023. It has entered a strategic partnership with WuXi Advanced Therapies for nula-cel manufacturing and appointed Darren Hart as senior vice president of development. As of September 30, 2022, Graphite had $305.1 million in cash, funding operations into Q4 2024.

Graphite Bio (NASDAQ: GRPH) announced the acceptance of two abstracts for the 64th American Society of Hematology Annual Meeting from December 10-13 in New Orleans. The research highlights the company's UltraHDR™ gene editing platform's potential to treat beta-thalassemia and sickle cell disease (SCD) with its investigational therapy, nula-cel. Notably, the beta-globin gene replacement strategy aims to restore healthy hemoglobin levels. The company expects to share proof-of-concept data for nula-cel in mid-2024.