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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 Holdings plc (Nasdaq: FRLN) announced the grant of non-statutory options for 81,000 ordinary shares to two newly hired employees on January 31, 2023. This grant, part of Freeline's 2021 Equity Inducement Plan, was approved by an independent subcommittee and serves as an inducement for the employees. Each option has an exercise price of $0.59 per share, reflecting the closing stock price on January 30, 2023, and has a maximum term of 10 years. The options vest over four years, with 25% vesting after the first year and the remainder vesting monthly thereafter.
Freeline Therapeutics (Nasdaq: FRLN) has published preclinical proof-of-concept data for its gene therapy candidate, FLT190, targeting Fabry disease in the journal Gene Therapy. Key findings include stable long-term expression of the enzyme α-galactosidase A and reduction of harmful substrates in key tissues, indicating potential efficacy. The company is currently conducting the MARVEL-1 Phase 1/2 clinical trial, with initial safety and efficacy data expected in the first half of 2023. This therapy aims to provide a one-time treatment option for individuals suffering from Fabry disease, a condition affecting approximately 16,000 people in key markets.
Freeline Therapeutics (Nasdaq: FRLN) announced the grant of non-statutory options to four new employees totaling 48,900 ordinary shares on December 30, 2022. The options, with an exercise price of $0.47 per share, were provided as a material inducement for employment and follow Nasdaq Listing Rule 5635(c)(4). Approved by an independent subcommittee, these options will vest over four years, with 25% vesting after the first year. Freeline is focused on innovative gene therapies aimed at treating chronic diseases such as Fabry and Gaucher diseases.
Freeline Therapeutics (NASDAQ: FRLN) announced its approval to transfer its American Depositary Shares from The Nasdaq Global Select Market to The Nasdaq Capital Market, effective November 30, 2022. The decision was based on the company meeting all criteria for the Nasdaq Capital Market except for the minimum bid price requirement of $1.00 per ADS for ten consecutive days. Nasdaq granted an extension until May 29, 2023, for the company to regain compliance, allowing for measures like a reverse share split. Freeline focuses on innovative gene therapies for chronic diseases.
Freeline Therapeutics has entered an agreement to sell its CMC-focused German subsidiary for $25 million, enhancing its cash runway into 2024. The company is focusing on developing FLT201 for Gaucher disease and FLT190 for Fabry disease, while ceasing investment in FLT180a for hemophilia B. The updated MARVEL-1 trial data for FLT190 shows sustained enzyme increases and good tolerability. Financial results indicate a decrease in cash reserves to $65.8 million, with a net loss of $66 million for the first nine months of 2022, reduced from the previous year's loss.
Freeline Therapeutics (Nasdaq: FRLN) announced that CEO Michael Parini will participate in a fireside chat at the Stifel Healthcare Conference on November 16 at 8:35 am ET in New York. This engagement will also include one-on-one investor meetings with senior management. A live webcast of the chat will be accessible on the Investors section of Freeline’s website, with an archived replay available for 90 days post-event. Freeline is focused on developing gene therapies for inherited diseases using their proprietary AAV vector technology.
Freeline Therapeutics (Nasdaq: FRLN) announced the grant of non-statutory stock options to three new employees on October 31, 2022. In total, 75,500 options were issued as part of an inducement offering, complying with Nasdaq Listing Rule 5635(c)(4). The exercise price is set at $0.76 per share, aligning with the last recorded sale on October 28, 2022. These options will vest over four years, starting with 25% on the first anniversary of the vesting commencement date. Freeline is focused on developing innovative gene therapies for hereditary systemic diseases.
Anokion SA, a clinical-stage biotechnology company, has announced key appointments to its leadership team to support its pipeline development, especially for KAN-101 and ANK-700. New executives include Dr. Alison Long as Chief Medical Officer, Glenn R. Booma as Chief Strategy Officer, and Kristie M. Grebe, Ph.D., promoted to Senior VP. Stephanie Haller also joins as Senior VP of Clinical Operations. The new leadership aims to enhance clinical development as Anokion prepares for Phase 2 trials in celiac disease and advances work on multiple sclerosis treatments.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced the granting of non-statutory options for 416,850 ordinary shares to five newly hired employees on September 30, 2022. These awards, compliant with Nasdaq Listing Rule 5635(c)(4), were approved by an independent subcommittee and are part of the 2021 Equity Inducement Plan. The options have an exercise price of $0.68 per share, vesting over four years. Freeline focuses on innovative gene therapies for inherited diseases, with ongoing clinical programs in hemophilia B, Fabry disease, and Gaucher disease Type 1.
Freeline Therapeutics (Nasdaq: FRLN) announced that the first patient has been dosed in the second cohort of its Phase 1/2 MARVEL-1 clinical trial evaluating FLT190 for Fabry disease. This milestone follows FDA alignment for patient dosing in the U.S. The trial, designed to assess the safety and efficacy of FLT190, aims to deliver durable enzyme activity with a single treatment. Initial results from the first cohort supported progression to the second dose. Safety and efficacy data updates are expected in the first half of next year.
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