Freeline Therapeutics Holdings Plc Stock Price, News & Analysis

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) reported its Q2 2022 financial results, highlighting progress in its clinical trials, including the B-LIEVE trial for FLT180a in hemophilia B where six patients were dosed. Initial positive safety and efficacy data were announced, with recent publications supporting their findings. The company also initiated new trial sites for FLT201 and FLT190. However, unrestricted cash decreased to $90 million, which is expected to sustain operations into mid-2023. Staffing changes include the appointment of Nicole Jones as Chief People Officer.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced on August 4, 2022, that it granted stock options to its newly hired Chief People Officer Nicole Jones and four other employees. The total of 240,000 and 35,250 options, respectively, is designed to incentivize these employees under Nasdaq Listing Rule 5635(c)(4). With an exercise price of $0.90 per share, the options will vest over four years. Freeline is focused on developing innovative gene therapies for inherited systemic diseases, with ongoing clinical programs for hemophilia B, Fabry disease, and Gaucher disease Type 1.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) reported positive results from the long-term follow-up of its FLT180a gene therapy candidate for hemophilia B, published in the New England Journal of Medicine. The study demonstrated durable expression of coagulation factor IX (FIX), resulting in reduced bleeding rates and minimized FIX replacement needs. Key findings include significant decreases in annualized bleeding and FIX consumption rates. Treatment was well tolerated, with no serious adverse events reported. These results support FLT180a's potential as a transformative therapy for hemophilia B.

Freeline Therapeutics (Nasdaq: FRLN) presented safety and initial efficacy data for FLT180a, its gene therapy for hemophilia B, at the ISTH Congress in London. The Phase 1/2 B-LIEVE trial showed a one-time dose of FLT180a resulted in protective levels of coagulation factor IX (FIX) without bleeding or FIX replacement in three patients. The treatment was well tolerated with no serious adverse events. However, some patients experienced mild increases in liver enzymes, indicating a need for refined immune management. The company continues to explore strategic options for FLT180a's development.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the grant of non-statutory options to a newly hired employee on June 30, 2022. The options allow for the purchase of 5,500 ordinary shares at an exercise price of $0.88 per share, reflecting the closing price of the company’s American Depositary Shares on June 29, 2022. The options vest over four years and are part of the 2021 Equity Inducement Plan adopted by Freeline’s board. This grant aligns with Nasdaq Listing Rule 5635(c)(4) and was approved by an independent subcommittee of the remuneration committee.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) will present new clinical data on its gene therapy candidate FLT180a at the ISTH Congress in London from July 9-13, 2022. The presentation will cover safety and initial efficacy data from the Phase 1/2 B-LIEVE trial, which aims to finalize the FLT180a dose ahead of a pivotal Phase 3 trial planned for 2023. The therapy targets hemophilia B by normalizing coagulation Factor IX levels. The poster presentation is scheduled for July 10, 2022, and will be accessible on Freeline's Investors webpage.

Freeline Therapeutics (Nasdaq: FRLN) has initiated dosing of the second cohort in its Phase 1/2 B-LIEVE trial for FLT180a in hemophilia B. The trial utilizes a low dose of 7.7e11 vg/kg, based on positive results from the first cohort, with safety data to be shared at the ISTH Congress in July. The Phase 3 trial is on schedule to begin in H1 2023. The Chief Medical Officer expressed confidence in the potential for a functional cure through gene therapy, aiming for predictable FIX normalization. Freeline plans to report updated data later in 2022 and early 2023.

On June 3, 2022, Freeline Therapeutics Holdings (Nasdaq: FRLN) announced the grant of stock options to its new CFO, Paul Schneider, and six other employees. In total, the company awarded 270,000 options to Schneider and 191,850 options to other hires. These options, which have an exercise price of $0.76 per share, are part of Freeline's 2021 Equity Inducement Plan and were approved by an independent board subcommittee. Vested over four years, the grants aim to incentivize the new team within Freeline's clinical-stage gene therapy framework.

Freeline Therapeutics Holdings plc (Nasdaq: FRLN) received a notice from Nasdaq on May 31, 2022, indicating non-compliance with the $1.00 minimum bid price requirement for its American Depositary Shares (ADS). The company has a 180-day deadline, until November 28, 2022, to regain compliance by maintaining a closing bid price of $1.00 per ADS for at least ten consecutive business days. Operations remain unaffected. Freeline focuses on developing transformative gene therapies for inherited diseases, with programs in Hemophilia B, Fabry disease, and Gaucher disease Type 1.