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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 a change to its American Depositary Shares (ADS) ratio, adjusting from 1:1 to 1:15 ahead of May 12, 2023. This reverse ADS split aims to help the company comply with Nasdaq's minimum bid price requirement. Current holders of certificated ADSs must surrender them for a new ADS in exchange for every fifteen existing ADSs. Uncertificated holders will receive automatic exchanges. The change is expected to proportionally increase Freeline’s ADS trading price, although no assurance is provided regarding future price levels. Despite this adjustment, there will be no impact on the underlying ordinary shares. The company continues to focus on developing transformative gene therapies, particularly its candidate FLT201 for treating Gaucher disease type 1.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) announced that CEO Michael Parini will present at the 22nd Annual Needham Virtual Healthcare Conference from April 17-20, 2023. The presentation is scheduled for 8 a.m. ET on April 19. Freeline's senior management will also hold one-on-one investor meetings during the event.
A live webcast of the presentation can be accessed through the Investors section of Freeline’s website, with an archived replay available for approximately 90 days afterward.
Freeline focuses on developing gene therapies for chronic debilitating diseases, utilizing their proprietary AAV vector technology. The company is progressing with FLT201, a novel gene therapy candidate currently in a Phase 1/2 clinical trial for Gaucher disease type 1. Freeline's operations extend from the UK to the United States.
Freeline Therapeutics Holdings reported its financial results for the year ending December 31, 2022, highlighting a focus on FLT201, a gene therapy for Gaucher disease type 1. The company anticipates initial data from Phase 1/2 trials of FLT201 in Q3 2023, showcasing its commitment to improving patient outcomes. In contrast, the development of FLT190 has been paused to streamline operations and extend its cash runway, anticipating cash sufficiency into Q2 2024. Financially, unrestricted cash fell from $117.7 million in 2021 to $47.3 million in 2022, with a net loss of $89.0 million, down from $140.4 million the prior year.
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) has announced a live conference call and webcast scheduled for April 4, 2023, at 8:00 a.m. ET to discuss its full year 2022 financial results and provide corporate updates. Participants are encouraged to join the call 10 minutes early, and a live webcast will be available on the company's website, with a replay for 90 days post-event. Freeline is focused on gene therapies using adeno-associated virus vectors to treat chronic diseases such as Fabry and Gaucher diseases, advancing innovative one-time treatments for patients.
LONDON, Feb. 10, 2023 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) has finalized the sale of its German subsidiary, Freeline Therapeutics GmbH, to Ascend Gene and Cell Therapies Ltd. for $25 million, subject to adjustments. The deal includes rights to related intellectual property, with Freeline retaining rights to its AAVS3 capsid. An intellectual property agreement was established to assign certain rights to Ascend while ensuring Freeline can still develop its product candidates. Additionally, a transition services agreement is in place for 18 months, allowing Freeline access to critical development capabilities.