Freeline Therapeutics Holdings Plc Stock Price, News & Analysis

Freeline Therapeutics announced that it will report its second quarter 2021 financial results on August 16, 2021. The company reiterated its unchanged guidance for key clinical milestones in 2021. Notable upcoming milestones include the FLT190 Phase 1/2 study for Fabry disease, FLT180a Phase 1/2 study for Hemophilia B, and FLT201 Phase 1/2 study for Gaucher disease Type 1. Additionally, Chief Medical Officer Julie Krop will be leaving the company, with Alison Long stepping in as interim CMO.

Freeline Therapeutics (Nasdaq: FRLN) has announced a leadership change with the appointment of James "Jay" Bircher as Chief Technical Operations Officer, effective July 1, 2021. Bircher brings nearly 30 years of operational expertise in biotechnology and will oversee regulatory compliance and manufacturing. Amit Nathwani, MD, PhD, will serve as interim Chief Scientific Officer following the departure of Romuald Corbau. This transition aims to bolster Freeline’s capabilities in advancing AAV gene therapies, with plans for a third clinical program by year-end 2021.

Freeline Therapeutics (FRLN) has completed dosing in the lowest dose cohort of its Phase 1/2 MARVEL-1 clinical trial for FLT190, a gene therapy for Fabry disease. CEO Theresa Heggie highlighted this milestone as a significant step forward, aided by easing COVID-19 restrictions and expanded study sites. The trial aims to evaluate safety and efficacy across four dose levels in about 10 adult males. Results showcasing FLT190's potential are expected by year-end, with the study monitoring various health metrics over nine months post-dosing.

Freeline Therapeutics Holdings plc (FRLN) reported Q1 2021 financial results, highlighting significant advancements in its gene therapy programs. The FLT190 Phase 1/2 trial for Fabry disease is progressing well, with data presentations expected by year-end. The company anticipates initiating FLT201 for Gaucher disease Type 1 by year-end, and the FLT180a trial for Hemophilia B is on track for site initiation. Cash and equivalents stand at $195.8 million. However, R&D expenses rose to $23.9 million, reflecting increased investments in clinical trials.

LONDON, May 12, 2021 – Freeline Therapeutics Holdings (Nasdaq: FRLN) announced participation in a Fireside Chat at the 2021 RBC Capital Markets Global Healthcare Conference on May 18 at 4:50 pm EDT. The event will include a webcast available in the Investors section of Freeline's website. Freeline focuses on developing AAV gene therapies for inherited diseases, with ongoing clinical programs targeting Hemophilia B and Fabry disease. The company aims to deliver one-time treatments that provide functional cures through its innovative gene therapy platform.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) presented six research posters at the ASGCT Annual Meeting 2021, showcasing advancements in their gene therapy platform. Key highlights include:

• Establishment of a high-throughput suspension platform for rAAV manufacturing.
• Development of a suspension cell-based AAV manufacturing process reducing costs.
• Innovative dosing assays enhancing vector genome titer quantification.
• Positive results from FLT190 for Fabry disease and FLT201 for Gaucher disease Type 1.

These findings underscore Freeline's commitment to pioneering gene therapies for debilitating diseases.

Freeline Therapeutics (Nasdaq: FRLN) announced six poster presentations at the ASGCT Annual Meeting from May 11-14, 2021. The presentations will showcase advancements in gene therapy, highlighting three gene therapies expected in clinical trials by year-end. Key topics include FLT201 for Gaucher Disease and AAV gene therapy for Fabry Disease. CEO Theresa Heggie emphasized the significance of these presentations in demonstrating the company’s ongoing progress and innovative approaches in gene therapy, which aim to provide functional cures for inherited diseases.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will participate in two upcoming virtual investor conferences. The Company will present at Chardan’s 5th Annual Genetic Medicines Manufacturing Summit on April 26, 2021, at 9:45 am ET. Additionally, Freeline will engage in one-on-one meetings at the 7th Annual Truist Securities 2021 Life Sciences Summit on May 4, 2021. The presentation from the Chardan summit will be accessible on Freeline's investor website. Freeline develops AAV-mediated gene therapies aimed at treating inherited systemic diseases.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) reported strong financial results for 2020 and outlined plans for three AAV gene therapy programs by year-end 2021. With a year-end cash position of $230 million, the company anticipates funding its upcoming clinical milestones. Phase 1/2 trial data for FLT180a, targeting Hemophilia B, indicates potential for durable normalization of Factor IX activity. Progress on FLT190 for Fabry disease and FLT201 for Type 1 Gaucher disease is also on track, with clinical trials expected to initiate by year's end.