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Freeline Therapeutics Holdings plc (Nasdaq: FRLN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing transformative gene therapies for chronic and debilitating diseases. The company's focus lies primarily on gene therapy solutions that address unmet medical needs, utilizing a next-generation AAV gene therapy platform developed by Professor Amit Nathwani, a leading authority in hematology from University College London (UCL).
Freeline's flagship program is FLT201, a highly differentiated gene therapy candidate targeting Gaucher disease type 1. This condition, caused by mutations in the GBA1 gene, leads to a deficiency in the glucocerebrosidase (GCase) enzyme, resulting in harmful substrate accumulation in organs such as the spleen, liver, bone, and lungs. FLT201 employs a rationally engineered longer-acting GCase variant designed to produce sustained enzyme levels and penetrate deeper tissues, potentially halting disease progression and improving patient outcomes with a single treatment. Early clinical data from the GALILEO-1 trial highlight the therapy’s potential, showing substantial reductions in key biomarkers and robust increases in plasma GCase activity.
Building on its work in Gaucher disease, Freeline has initiated a research program targeting GBA1-linked Parkinson’s disease. This program aims to extend the therapeutic benefits of its engineered GCase variant to patients suffering from Parkinson's disease due to GBA1 mutations. These mutations significantly increase the risk of Parkinson’s disease, leading to earlier onset, more severe symptoms, and faster progression to dementia. The preclinical data for this program is promising, showcasing the gene therapy’s enhanced enzyme activity in various cell lines.
Headquartered in the UK, with operations in the United States, Freeline is driven by its commitment to employing innovative gene therapy techniques to provide life-changing treatments. The company leverages proprietary AAVS3 capsid technology and novel promoters and transgenes to deliver functional copies of therapeutic genes to liver cells, ensuring persistent and effective protein expression. Freeline’s pipeline promises significant advancements, with FLT201 leading the charge in ongoing clinical trials and additional programs in the research phase.
Freeline's recent achievements and financial updates reflect its proactive stance in advancing its mission. The company’s financial results for the second quarter of 2023 reveal significant progress and a solid strategic focus, emphasizing the advancement of FLT201 as its top priority. The successful dosing of patients in the GALILEO-1 trial and the unveiling of the GBA1-linked Parkinson’s disease program underline Freeline's relentless pursuit of innovative treatments for genetic disorders.
Freeline Therapeutics (Nasdaq: FRLN) announced the grant of non-statutory options to two newly recruited employees, totaling 64,050 shares. The grant, approved by an independent committee, follows Nasdaq Listing Rule 5635(c)(4) and aligns with Freeline’s 2021 Equity Inducement Plan. Each option has an exercise price of $0.83 per share, based on the previous day's closing price. The options vest over four years, with a portion becoming available after the first year.
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.
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