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Freeline Therapeutics Holdings plc (FRLN)

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Previous Close9.67
Open9.81
Bid0.00 x 1000
Ask0.00 x 800
Day's Range9.46 - 9.98
52 Week Range8.31 - 21.69
Volume24,653
Avg. Volume28,165
Market Cap347.327M
Beta (5Y Monthly)N/A
PE Ratio (TTM)N/A
EPS (TTM)N/A
Earnings DateMay 17, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est24.88
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  • 3 “Strong Buy” Stocks Under $10 With Triple-Digit Upside Potential
    TipRanks

    3 “Strong Buy” Stocks Under $10 With Triple-Digit Upside Potential

    You don’t have to pay three-digit sums to find compelling investing opportunities. It’s time to look outside the box at some cheap stocks top analysts are cheering right now. Among the stocks that are getting the thumbs up are three that show a strongly attractive profile for retail investors: an initial price below $10 per share, a Strong Buy rating from the Street, and a triple digit upside potential. We’ve used the TipRanks database to pull up these stocks and find out what else makes them so compelling. Let's take a closer look. RedHill Biopharma (RDHL) The first stock we’re looking at, RedHill Biopharma, is a biopharmaceutical firm that focuses its research efforts on gastrointestinal illnesses. The company has an active product line – 6 drug candidates at the clinical stage of research and development, and three products with approval in the US or globally and now in the commercialization process. The three drugs with approval are Movantik, a treatment for opioid-induced constipation (a common side effect) which is approved for use globally but excluding Europe, Canada, and Israel; Talicia, a treatment for H. pylori infection (a common cause of stomach ulcers) which received FDA approval in November of 2019; and Aemcolo, a treatment for ‘traveler’ diarrhea, which has a license for exclusive use in the US. These three drugs saw growth in prescriptions and market share during 2020, and in the full-year results RedHill reported top line revenues of $64 million with a gross profit of $27.5 million. In March of this year, the company reported having $100 million in cash on hand. Having plenty of cash and a profitable product line puts RedHill in a solid position to continue its development activities. The company has several novel therapeutics in the pipeline as potential treatments for COVID-19. These include Opaganib, which is in an ongoing Phase 2/3 study on hospitalized patients; RHB-107, which is also in an ongoing Phase 2/3 study, but for non-hospitalized patients. The clinical pipeline also includes RHB-204, which is in a Phase 3 trial as a treatment for pulmonary NTM disease. All of this caught the attention of analyst Raghuram Selvaraju from H.C. Wainwright, who titled his initiation of coverage report on this stock, ‘A Trifecta of Products With a Pipeline Punch.’ "From our vantage point, RedHill is building the next leading gastroenterology-focused specialty pharmaceuticals franchise in the U.S. market, while also advancing an extensive pipeline of rapidly-maturing drug candidates in an array of fields including oncology, respiratory conditions and infectious disease," Selvaraju noted. The analyst continued, "In our view, Movantik, Talicia and Aemcolo alone could generate peak annual sales of $1.1B by 2028. Opaganib, upamostat and RHB-204—the only components of RedHill's extensive pipeline that we currently model—could contribute over $400M in revenue in the early 2030s, with RHB-204 potentially providing a durable long-term revenue stream beyond 2040 if pending patent claims are issued. We believe, therefore, that total sales of the products that we forecast could enable RedHill to sustain a >$1B revenue base for a lengthy period of time." In line with his optimistic take, Selvaraju rates RDHL a Buy, along with a $23 price target. This target suggests the stock will be changing hands for a 231% premium a year from now. (To watch Selvaraju’s track record, click here) Overall, based on all the above factors, Wall Street analysts are thoroughly impressed with RDHL. It boasts 100% Street support, or 4 Buy ratings in the last three months, making the consensus a Strong Buy. Shares are selling for $6.94 each, and the average target of $20.50 indicates a possible upside of 195% by next year. (See RDHL stock analysis on TipRanks) Freeline Therapeutics (FRLN) The next stock, Freeline Therapeutics, is working on gene therapies for debilitating, chronic diseases, including bleeding disorders. The company has four drugs in the development pipeline, two as treatments for hemophilia, one for Fabry disease, and one for Gaucher disease. Freeline follows a proprietary liver-based investigational gene therapy approach in its research. Three of the company’s drug candidates are in clinical trials. FLT190, under investigation as a treatment for Fabry disease, is in a Phase 1/2 dose-finding study, with data expected to be presented before the end of this year. FLT201 is also in a Phase 1/2 dose-finding study, for Gaucher disease. This study is expected to be in the clinic before the end of this year. Finally, FLT180a, a drug candidate under investigation as a treatment for hemophilia B, is in a Phase 1/2 dose-confirmation study, and is on track to initiate trial sites by year’s end. Among the bulls is H.C. Wainwright analyst Patrick Trucchio who is upbeat about the prospects for the company's Gaucher program. "With limited competition, we believe the Gaucher program is Freeline's most valuable program... Freeline presented positive data at the WORLD Symposium... We believe that these data suggest FLT201 may be able to deliver sustained GCase expression in difficult-to-reach tissues. Furthermore, we believe learnings from data generated in humans to-date in the FLT180a and FLT190 programs, particularly around dosing and immune suppression, could help accelerate the FLT201 program... We estimate FLT201 could generate aggregate revenues of more than $8B; risk-adjusted, we estimate this program is worth $12/share," Trucchio explained. The analyst summed up, "We believe a recent sell-off in FRLN shares... has created a compelling buying opportunity ahead of data updates on FLT180a, FLT190, and FLT201." To this end, Driscoll rates FRLN a Buy along with a $30 price target. Should his thesis play out, a potential upside of ~257% could be in the cards. (To watch Trucchio’s track record, click here) Trucchio is not alone in taking a bullish view here; there are 6 recent reviews of this stock and all are positive, making for a unanimous Strong Buy consensus rating. The shares are priced at $8.41 with an average price target of $24.50 implying an upside of 191%. (See FRLN stock analysis on TipRanks) Clene (CLNN) Last but not least is Clene, a clinical-stage biopharmaceutical company pursuing a unique track in the treatment of neurodegenerative diseases. The company uses nanotechnology to treat bioenergetic failure, and underlying factor in many neurological conditions. The company is developing bioenergetic nanocatalysts, a new class of drugs, to ‘jump start’ neurorepair through an energy-enhancing bioenergetic catalysis. In short, the company’s approach is to improve bio functions at the cellular level, so that the body can repair itself. Clene has four drug candidates it its pipeline. The leading one, CNN-Au8, is described as a concentrated nanocrystalline gold (Au) suspension that drives critical cellular bioenergetic reactions in the central nervous system. CNN-Au8 is undergoing several concurrent clinical trials, including a Phase 3 trial for amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) and Phase 2 trials for multiple sclerosis (MS) and Parkinson’s disease. All of these are progressive, chronic, degenerative conditions of the neuromuscular system. The Phase 3 trial of CNN-Au8 reached the 50% enrollment milestone during Q1. Full enrollment is expected before the end of this year, and topline data is expected to become available during 1H22. Further updates on the company’s various other clinical trial programs are scheduled for later this year. This company went public in December of last year through a SPAC merger transaction. The merger, with Tottenham Acquisition I Limited brought proceeds of $31.9 million, and saw CLNN shares debut on the NASDAQ on December 31 at $9.01 per share. Covering CLNN for Cantor Fitzgerald, analyst Charles Duncan set an Overweight (i.e. Buy) rating and a $22 price target that indicates room for ~129% share appreciation from the current $9.63 share price. (To watch Duncan’s track record, click here) “We see the non-specificity of ‘Au8 as a positive for broad applicability to a range of diseases in which oxidative stress and metabolic dysfunction is a key driver of pathophysiology. In addition, although crystalline gold has long been thought to have metabolic activity, it is not until we’ve seen the convergence of deeply scientific knowledge of nanocrystal technology with management capabilities in neurobiology and drug development, that we’ve been compelled to consider the therapeutic potential of gold in the treatment of neurodegenerative diseases," Duncan opined. The analyst added, "Clene owns patented technology which enables gold nanocrystals to form into specific shapes that are particularly conducive to facilitating nanocatalytic activity and filtering toxic particles from the gold surface to drive differentiated clinical profile, potentially opening the door to broad deployment within medicine.” In its short time on the public markets, CLNN has attracted 4 analyst reviews – and all are positive, making the analyst consensus a Strong Buy. The stock has an average price target of $22.25, suggesting a 131% one-year upside from current levels. (See CLNN stock analysis on TipRanks) To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

  • Freeline Reports First Quarter 2021 Financial Results and Recent Business Highlights
    GlobeNewswire

    Freeline Reports First Quarter 2021 Financial Results and Recent Business Highlights

    FLT190 Phase 1/2 dose-finding study in Fabry disease on track to dose additional patients; Company to present data by year-end FLT201 Phase 1/2 dose-finding study in Gaucher disease Type 1 expected to be in the clinic by year-end FLT180a Phase 1/2 dose-confirmation study in Hemophilia B on track to initiate trial sites by year-end LONDON, May 17, 2021 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), a clinical-stage biotechnology company developing transformative AAV-mediated gene therapies for patients suffering from inherited systemic debilitating diseases, today reported financial results for the first quarter of 2021 and provided an update on recent business highlights. “2021 is an important year of execution for Freeline and we are encouraged by the progress we see in patient identification and screening in the FLT190 Phase 1/2 dose-finding trial for the treatment of Fabry disease,” said Theresa Heggie, Chief Executive Officer of Freeline. “The easing of COVID restrictions and our strategic geographical diversification of trial sites, along with the ongoing identification of patients through our close working relationships with investigators and patient organizations, give us confidence with respect to recruitment into this important trial for people with Fabry disease. We look forward to sharing more information about study progress later this year.” “We are advancing our FLT201 program for the treatment of Gaucher disease Type 1 into the clinic in a Phase 1/2 dose-finding study, which we plan to initiate by year-end,” continued Ms. Heggie. “Our FLT180a program for the treatment of Hemophilia B also continues to progress and we will initiate the dose-confirmation trial later this year.” “We also continue to leverage our differentiated AAVS3 technology platform, which underlies each of our programs and consists of a proprietary, rationally-designed capsid, optimized expression cassette design, novel protein engineering capabilities, rapid candidate screening and cutting-edge analytics,” added Ms. Heggie. “We are committed to providing patients with safe and effective gene therapy and our potent platform, together with a long-standing focus on quality, provides us with the possibility of delivering functional cures to patients and the ability to address indications considered beyond the reach of first-generation vectors.” Recent Business Highlights Continued enrollment in the ECLIPSE run-in study for FLT180a for the treatment of Hemophilia B, supports enrollment in the Phase 1/2 dose-confirmation trial: Freeline continues to enroll patients into the ECLIPSE run-in study and anticipates that this will accelerate enrollment in the Phase 1/2 dose-confirmation trial, which will include only a small number of patients.Presented FLT190 data that demonstrated GLA uptake and metabolic cross-correction in Fabry disease-relevant cell lines: In May 2021, the Company presented data at the American Society of Gene and Cell Therapy (“ASGCT”) Annual Meeting 2021 demonstrating GLA uptake and metabolic cross-correction in Fabry disease relevant cell lines supportive of the Company’s ongoing development of FLT190.Advanced FLT201 for the treatment of Gaucher disease Type 1 in key markets: The Company previously announced that it filed a Clinical Trial Authorization (“CTA”) with the UK Medicines and Healthcare products Regulatory Agency (“MHRA”) and has also completed a similar filing with the Ministry of Health (“MOH”) in Israel, a key market for Gaucher disease Type 1.Presented data on foundational technology supporting the Company’s robust gene therapy platform: In May 2021, Freeline presented four posters at ASGCT, which detailed advancements in its high-throughput rAAV manufacturing platform optimization and candidate selection, development scale-up of suspension cell-based AAV manufacturing and quantification assay strategy for AAV-based gene therapies, as well as assay development to measure transduction efficiency.Strengthened the Freeline Board of Directors: In March 2021, the Company announced the appointment of Colin Love, PhD to the Freeline Board of Directors. Dr. Love has extensive experience in manufacturing complex biotechnology products and currently serves as the Chief Operating Officer of Replimune.Strengthened the leadership team: Today, the Company announced the appointment of Eric Fink to the Freeline leadership team. Effective May 24, 2021, Mr. Fink will join Freeline in a newly-created position of Chief Human Resources Officer (“CHRO”). Mr. Fink joins from Global Blood Therapeutics, Inc., where he was the CHRO. Mr. Fink brings significant expertise in building organizations as they progress toward commercialization, and he will be based in the Company’s New York office. The role builds on the recent appointment of Michael Parini, who joined the Company in March 2021 from Vertex, Inc. in the newly-created role of President and Chief Operating Officer. Mr. Parini is a global pharmaceutical executive and a recognized biotechnology leader in areas such as corporate strategy, operational effectiveness and building high-performing organizations. Mr. Parini is based in the Company’s New York office. Selected Anticipated Milestones in 2021 Progress dose escalation for the FLT190 Phase 1/2 dose-finding trial in Fabry disease.Commence clinical development of FLT201 for Gaucher disease Type 1 by initiating a Phase 1/2 dose-finding trial.Report four-year durability data for FLT180a from the Company’s Phase 1/2 dose-finding trial in Hemophilia B.Initiate Phase 1/2 dose-confirmation trial for FLT180a to confirm both the dose and immune management regimen for the planned pivotal Phase 3 trial. The Company is targeting full enrollment of the Phase 1/2 dose-confirmation trial during the first half of 2022 with a six-month data readout by the end of 2022.Complete IND/CTA enabling studies for FLT 210 for Hemophilia A. Q1 2021 Financial Highlights Cash Position: Cash and cash equivalents were $195.8 million as of March 31, 2021, as compared to $230.0 million as of December 31, 2020. Based on the Company’s current operating plan, Freeline expects that its current level of cash and cash equivalents will enable the Company to fund its operating expenses into the third quarter of 2022. R&D Expenses: Research and development (“R&D”) expenses for the three months ended March 31, 2021 were $23.9 million, as compared to $17.5 million for the same period in 2020. The increase of $6.4 million was driven by an increased investment in activities related to the current and proposed clinical trials for FLT201 and FLT210 and overall research and development, which includes earlier pipeline programs, discovery and further development of the Freeline platform. G&A Expenses: General and administrative (“G&A”) expenses for the three months ended March 31, 2021 were $10.1 million, as compared to $3.7 million for the same period in 2020. The increase of $6.3 million was driven primarily by legal and professional fees related to expenses associated with the Company’s obligations as a public company, including annual and periodic reporting, equity compensation programs, more extensive governance requirements and increased audit fees and expenses related to US GAAP requirements, as well as an increase in headcount and related personnel costs. As of March 31, 2021, the Company had 35,843,902 ordinary shares outstanding. About Freeline Therapeutics Freeline is a clinical-stage biotechnology company developing transformative adeno-associated virus (“AAV”) vector-mediated systemic gene therapies. The Company is dedicated to improving patient lives through innovative, one-time treatments that provide functional cures for inherited systemic debilitating diseases. Freeline uses its proprietary, rationally-designed AAV vector, along with novel promoters and transgenes, to deliver a functional copy of a therapeutic gene into human liver cells, thereby expressing a persistent functional level of the missing protein into the patient’s bloodstream. The Company’s integrated gene therapy platform includes in-house capabilities in research, clinical development, manufacturing and commercialization. The Company has clinical programs in Hemophilia B and Fabry disease, as well as preclinical programs in Gaucher disease and Hemophilia A. Freeline is headquartered in the UK and has operations in Germany and the US. Forward-Looking Statements This press release contains statements that constitute “forward looking statements” as that term is defined in the United States Private Securities Litigation Reform Act of 1995, including statements that express the Company’s opinions, expectations, beliefs, plans, objectives, assumptions or projections regarding future events or future results, in contrast with statements that reflect historical facts. Examples include, among other topics, discussion of the Company’s strategies, anticipated operating and financial performance and financial condition; the Company’s expectations regarding its use of cash and cash runway; statements regarding the initiation, timing, progress and results of the Company’s preclinical studies and clinical trials, including the initiation of the Phase 1/2 dose confirmation trial for FLT180a and data readouts from that trial, progress with respect to the dose-escalation for the Phase 1/2 clinical study of FLT190, commencement of clinical trials in our FLT201 program, and completion of proof-of-concept studies of FLT210; statements that the Company’s updated clinical development plan for FLT180a will allow it to address CMC feedback from the FDA in parallel with the Phase 1/2 dose confirmation trial; business plans and prospects; capital allocation objectives; and manufacturing, research, pipeline, and clinical trial plans, including anticipated clinical development milestones for the Company’s product candidates. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” or “expect,” “may,” “will,” “would,” “could” or “should,” the negative of these terms or similar expressions. Forward looking statements are based on management’s current beliefs and assumptions and on information currently available to the Company, and you should not place undue reliance on such statements. Forward-looking statements are subject to many risks and uncertainties, including the Company’s recurring losses from operations; the uncertainties inherent in research and development of the Company’s product candidates, including statements regarding the timing of initiation, completion and the outcome of clinical studies or trials and related preparatory work and regulatory review, regulatory submission dates, regulatory approval dates and/or launch dates, as well as risks associated with preclinical and clinical data, including the possibility of unfavorable new preclinical, clinical or safety data and further analyses of existing preclinical, clinical or safety data; the Company’s ability to design and implement successful clinical trials for its product candidates; whether the Company’s cash resources will be sufficient to fund the Company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements for the Company’s expected timeline; the potential for a pandemic, epidemic or outbreak of infectious diseases in the US, UK or EU, including the COVID-19 pandemic, to disrupt and delay the Company’s clinical trial pipeline; the Company’s failure to demonstrate the safety and efficacy of its product candidates; the fact that results obtained in earlier stage clinical testing may not be indicative of results in future clinical trials; the Company’s ability to enroll patients in clinical trials for its product candidates; the possibility that one or more of the Company’s product candidates may cause serious adverse, undesirable or unacceptable side effects or have other properties that could delay or prevent their regulatory approval or limit their commercial potential; the Company’s ability to obtain and maintain regulatory approval of its product candidates; the Company’s limited manufacturing experience which could result in delays in the development, regulatory approval or commercialization of its product candidates; and the Company’s ability to identify or discover additional product candidates, or failure to capitalize on programs or product candidates. Such risks and uncertainties may cause the statements to be inaccurate and readers are cautioned not to place undue reliance on such statements. We cannot guarantee that any forward-looking statement will be realized. Should known or unknown risks or uncertainties materialize or should underlying assumptions prove inaccurate, actual results could vary materially from past results and those anticipated, estimated or projected. Investors are cautioned not to put undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters can be found in our Annual Report on Form 20-F for the fiscal year ended December 31, 2020 and in our subsequent reports on Form 6-K, in each case including in the sections thereof captioned “Cautionary Statement Regarding Forward-Looking Statements” and “Item 3.D. Risk factors.” Many of these risks are outside of the Company’s control and could cause its actual results to differ materially from those it thought would occur. The forward-looking statements included in this press release are made only as of the date hereof. The Company does not undertake, and specifically declines, any obligation to update any such statements or to publicly announce the results of any revisions to any such statements to reflect future events or developments, except as required by law. For further information, please reference the Company’s reports and documents filed with the U.S. Securities and Exchange Commission (the “SEC”). You may review these documents by visiting EDGAR on the SEC website at www.sec.gov. Contact David S. ArringtonVice President Investor Relations & Corporate CommunicationsFreeline Therapeuticsdavid.arrington@freeline.life +1 (646) 668 6947 Freeline Therapeutics Holdings plcUnaudited Condensed Consolidated Statements of Operations Data(in thousands of U.S. dollars, except per share data) Three Months Ended March 31, 2021 2020 OPERATING EXPENSES: Research and development$ 23,863 $ 17,457 General and administrative 10,078 3,735 Total operating expenses 33,941 21,192 LOSS FROM OPERATIONS: (33,941) (21,192)OTHER INCOME (EXPENSE) NET: Other income (expense), net (1,733) 863 Interest income, net 140 53 Benefit from R&D tax credit 598 3,702 Total other income (expense), net (995) 4,618 Loss before income taxes (34,936) (16,574)Income tax expense (9) (131)Net loss (34,945) (16,705)Net loss per share attributable to ordinary shareholders—basic and diluted$ (0.98) $ (1.85)Weighted average ordinary shares outstanding—basic and diluted 35,655,443 9,010,843 Freeline Therapeutics Holdings plcUnaudited Condensed Consolidated Balance Sheet Data(in thousands of U.S. dollars, except per share data) March 31, December 31, 2021 2020 ASSETS CURRENT ASSETS: Cash and cash equivalents$ 195,765 $ 229,974 Account receivable — 97 Prepaid expenses and other current assets 27,718 28,105 Total current assets 223,483 258,176 Property and equipment, net 10,093 8,608 Intangible assets, net 16 23 Other non-current assets 1,655 1,805 Total assets$ 235,247 $ 268,612 LIABILITIES, PREFERRED SHARES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable$ 5,528 $ 8,093 Accrued expenses and other current liabilities 10,292 10,719 Total current liabilities 15,820 18,812 Total liabilities 15,820 18,812 Commitments and contingencies SHAREHOLDERS’ EQUITY: Deferred shares 137 155 Additional paid-in capital 458,857 456,293 Accumulated other comprehensive loss 11,368 9,342 Accumulated deficit (250,935) (215,990)Total shareholders’ equity 219,427 249,800 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY$ 235,247 $ 268,612

  • Freeline to Participate at the 2021 RBC Capital Markets Global Healthcare Conference
    GlobeNewswire

    Freeline to Participate at the 2021 RBC Capital Markets Global Healthcare Conference

    LONDON, May 12, 2021 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), a clinical-stage biotechnology company developing transformative AAV gene therapies for patients suffering from inherited systemic debilitating diseases, today announced that senior management will participate in a Fireside Chat at the virtual 2021 RBC Capital Markets Global Healthcare Conference on Tuesday, May 18, 2021 at 4:50 pm EDT. A webcast of the event will be available on the Investors section of the Freeline website. Senior management will also participate in virtual one-on-one meetings with investors at the conference. About Freeline Therapeutics Freeline is a clinical-stage biotechnology company developing transformative adeno-associated virus (“AAV”) vector-mediated systemic gene therapies. The Company is dedicated to improving patient lives through innovative, one-time treatments that provide functional cures for inherited systemic debilitating diseases. Freeline uses its proprietary, rationally-designed AAV vector, along with novel promoters and transgenes, to deliver a functional copy of a therapeutic gene into human liver cells, thereby expressing a persistent functional level of the missing protein into the patient’s bloodstream. The Company’s integrated gene therapy platform includes in-house capabilities in research, clinical development, manufacturing and commercialization. The Company has clinical programs in Hemophilia B and Fabry disease, as well as preclinical programs in Gaucher disease and Hemophilia A. Freeline is headquartered in the UK and has operations in Germany and the US. Contact David S. ArringtonVice President Investor Relations & Corporate CommunicationsFreeline Therapeuticsdavid.arrington@freeline.life+1 (646) 668 6947