FLT-210

Six patients dosed in B-LIEVE trial of FLT180a in hemophilia B in four months and initial and emerging cohort one data reported, followed by NEJM publication of B-AMAZE long-term data Continued progress in FLT190 in Fabry disease and FLT201 in Gaucher disease, with new country and site initiations paving the way for delivery of key milestones in both programs Leadership team further strengthened by appointing new Chief People Officer LONDON, Aug. 09, 2022 (GLOBE NEWSWIRE) -- Freeline Therapeutics Holdings plc (Nasdaq: FRLN) today reported financial results and business highlights for the second quarter of 2022. “In the second quarter, we continued to make progress in demonstrating the value of our portfolio of clinical programs and the strong foundation provided by our potent AAVS3 capsid. We dosed both the first and second cohorts in the B-LIEVE trial, a total of six patients, between March and June, and reported encouraging initial and emerging cohort one data in July,” said Michael Parini, Chief Executive Officer of Freeline. “In addition, with the recent publication of the B-AMAZE long-term follow-up data in NEJM and related broad media coverage highlighting the potential benefit for patients, our confidence in the strength of our foundational science is high and we look forward to extending the application of this strong scientific underpinning to our other clinical programs.” “In this regard, we are bringing the same sense of urgency and strong executional focus exhibited in our FLT180a program to our lysosomal storage disease programs, initiating new trial sites in current and multiple additional countries and identifying and screening more eligible patients to advance our Phase 1/2 dose-finding trials of FLT201 in Gaucher disease and FLT190 in Fabry disease,” said Parini. “The increased focus on these programs positions us well to demonstrate their value as potential best-in-class and/or first-in-class gene therapy candidates in these debilitating diseases affecting significant patient populations.” "We are advancing the evaluation of our strategic options for FLT180a for hemophilia B and are reviewing how to best streamline operations and prioritize our efforts on the highest value activities, including progressing FLT201 for Gaucher disease and FLT190 for Fabry disease and identifying additional research projects in new disease areas. Through these efforts, we are looking to improve our efficiency and extend our cash runway,” said Paul Schneider, Chief Financial Officer of Freeline. “We anticipate concluding this comprehensive review and executing on prioritized activities in the second half of this year as we remain focused on delivering value to patients with debilitating disease and shareholders alike.” “Finally, we continued to strengthen Freeline’s leadership team by adding Nicole Jones as our new Chief People Officer,” said Michael Parini. “Nicole’s experience in talent development and attraction will be instrumental in advancing Freeline’s capabilities to position the company for long-term success.” Program Updates FLT180a in hemophilia B Following completion of the dosing of cohort one in the Phase 1/2 dose-confirmation B-LIEVE trial in April, dosing of the second cohort was completed in June, using the same FLT180a dose (7.7e11 vg/kg) and proactive immune management as in the first cohort, consistent with the advice of the trial’s independent Data Monitoring Committee based on initial cohort one data. Positive initial safety and efficacy data from the first B-LIEVE cohort were presented at the International Society on Thrombosis and Haemostasis (ISTH) Congress in London on July 10, and updates from that cohort and initial trends from the second cohort were reported the same day. Positive long-term follow-up data from the Phase 1/2 dose-finding B-AMAZE trial of FLT180a were published in The New England Journal of Medicine (NEJM) on July 21. The company expects to report updated safety and efficacy data from the B-LIEVE trial in the second half of the year while it evaluates strategic options for FLT180a, which include, but are not limited to, seeking a partner that would enable the continuation of FLT180a through Phase 3 development. FLT190 in Fabry disease Dosing in the second cohort (1.5e12 vg/kg) in the Phase 1/2 dose-finding MARVEL-1 trial and a further program update are expected in the second half of 2022. FLT201 in Gaucher disease Dosing in the Phase 1/2 dose-finding GALILEO-1 trial is expected in the second half of 2022 with initial safety and efficacy data expected to be reported in the first half of 2023. Corporate Updates Effective July 11, Nicole Jones, SPHR, became Freeline’s new Chief People Officer. Ms. Jones previously served as Head of Global Talent Management & Leadership Development at Merck and brings 25 years of industry experience in senior global Human Resources and talent management roles at companies including Alexion, Fidelity Investments and Raytheon. She holds a Master of Business Administration from Meredith College and a Bachelor of Science in Economics from North Carolina State University. Freeline’s new CFO, Paul Schneider, joined the company on May 16, 2022, as announced in April. Q2 2022 Financial Highlights Cash Position: Unrestricted cash and cash equivalents were $90.0 million as of June 30, 2022, as compared to $117.7 million as of year-end 2021. Freeline expects that its current level of cash and cash equivalents will enable the company to fund its operating expenses into the second half of 2023.Research and Development (R&D) Expenses: R&D expenses for the six months ended June 30, 2022 were $38.8 million, as compared to $48.1 million for the same period in 2021. The decrease of $9.3 million was primarily driven by decreases in spending for personnel expenses and non-cash share-based compensation expense in conjunction with both our reduction in force executed in 2022 as well as executive turnover. In addition, the company saw a decrease in expenditures for our FLT201 program, mainly due to a decrease in CMO fees for clinical materials which were manufactured in 2021 to support the ongoing trial, and in spending related to FLT210, our former therapy candidate for the treatment of hemophilia A which was discontinued in 2021. These decreases were partially offset by an increase primarily for FLT190 related to ongoing clinical trial costs for the Phase 1/2 MARVEL-1 clinical trial in 2022.General and Administrative (G&A) Expenses: G&A expenses decreased by $8.3 million to $16.3 million for the six months ended June 30, 2022, as compared to $24.6 million for the same period in 2021. The decrease was driven by lower personnel expenses and related non-cash share-based compensation expenses, legal and professional fees, and other related expenses.As of June 30, 2022, the Company had 64,972,301 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 may 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 or dysfunctional protein into the patient’s bloodstream. The company’s integrated gene therapy platform includes in-house capabilities in research, clinical development and commercialization. The company has clinical programs in hemophilia B, Fabry disease, and Gaucher disease Type 1. Freeline is headquartered in the UK and has operations in Germany and the U.S. 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. All statements, other than historical facts, including statements regarding the potential of our product candidates to become the best-in-class and/or first-in-class gene therapy candidates, the timing of initiation, enrollment, continuation, completion and the outcome of clinical trials and related preparatory work, including the Phase 1/2 B-LIEVE dose-confirmation clinical trial of FLT180a, dosing of the second dose cohort in the Phase 1/2 MARVEL-1 dose-finding clinical trial of FLT190, and dosing in the Phase 1/2 dose-finding clinical trial of FLT201 and data readouts from such trials, the timing and outcome of the company’s evaluation of strategic options for FLT180a and prioritization efforts, and the Company’s expectations regarding its use of cash and cash runway, are forward-looking statements. In some cases, you can identify such forward-looking statements by terminology such as “anticipate,” “intend,” “believe,” “estimate,” “plan,” “seek,” “project” “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, enrollment, continuation, 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 United States, United Kingdom or European Union, 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; business interruptions resulting from geopolitical actions, including global hostilities, war and terrorism, global pandemics or natural disasters, including earthquakes, typhoons, floods and fires; 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 history, 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. The Company 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 the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2021, and in 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. Unaudited Condensed Consolidated Statement of Operations Data(in thousands of U.S. dollars, except share and per share data) For the Six Months Ended June 30, 2022 2021 OPERATING EXPENSES: Research and development$38,785 $48,132 General and administrative 16,278 24,615 Total operating expenses 55,063 72,747 LOSS FROM OPERATIONS: (55,063) (72,747)OTHER INCOME (EXPENSE) NET: Other income (expense), net 2,973 (3,367)Interest income, net 335 265 Benefit from R&D tax credit 721 1,050 Total other income (expense), net 4,029 (2,052)Loss before income taxes (51,034) (74,799)Income tax expense (46) (16)Net loss$(51,080) $(74,815)Net loss per share attributable to ordinary shareholders—basic and diluted (0.95) (2.10)Weighted average ordinary shares outstanding—basic and diluted 53,587,167 35,668,423 Unaudited Condensed Consolidated Balance Sheet Data (in thousands of U.S. dollars) June 30, December 31, 2022 2021 ASSETS CURRENT ASSETS: Cash and cash equivalents$89,998 $117,662 Prepaid expenses and other current assets 6,115 10,630 Total current assets 96,113 128,292 NON-CURRENT ASSETS: Property and equipment, net 8,782 9,906 Intangible assets, net 4 8 Operating lease right of use assets 53,496 — Other non-current assets 3,739 2,919 Total assets$162,134 $141,125 LIABILITIES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable$7,881 $5,187 Accrued expenses and other current liabilities 7,217 15,497 Operating lease liabilities, current 11,000 — Total current liabilities 26,098 20,684 NON-CURRENT LIABILITIES: Operating lease liabilities, non-current 46,407 — Total liabilities$72,505 $20,684 SHAREHOLDERS’ EQUITY: Deferred shares 137 137 Additional paid-in capital 498,449 467,213 Accumulated other comprehensive gain (1,496) 9,472 Accumulated deficit (407,461) (356,381)Total shareholders’ equity 89,629 120,441 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY$162,134 $141,125 Media Contact: Arne Naeveke, PhDVice President, Head of Corporate Communicationsarne.naeveke@freeline.life +1 617 312 2521 IR Contact: investor@freeline.life

On track for three programs in the clinic by year end; trial site initiation for FLT180a for Hemophilia B and FLT201 for Gaucher disease Type 1 expected by year end; program for FLT190 for Fabry disease progressing Completed first dose cohort for FLT190 Phase 1/2 dose-finding trial and advancing to next dose level; data presented by year end Updated durability data from FLT180a Phase 1/2 dose-finding trial presented by year end Defined Company strategic priorities to accelerate value creation; near-term efficiencies extend cash runway into first quarter of 2023 LONDON, Aug. 16, 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 announced that Michael J. Parini has succeeded Theresa Heggie as Chief Executive Officer (“CEO”). The Company also reported financial results for the second quarter of 2021 and provided updates on its lead program FLT180a for Hemophilia B, FLT190 for Fabry disease, FLT201 for Gaucher disease Type 1 and FLT210 for Hemophilia A. “Today we are pleased to announce that Freeline’s Board of Directors has appointed Michael J. Parini as CEO and Executive Director of the Company, effective immediately,” said Dr. Chris Hollowood, Chairman of Freeline. “Michael has a long track record of building strong executive leadership teams and has had a significant positive impact on Freeline since he joined the Company from Vertex Pharmaceuticals. In a short period of time, he has mobilized program execution across our pipeline, increased focus on our core scientific and platform technology capabilities, and driven efficiencies across the organization that have extended our cash runway. In doing so, Michael has demonstrated his ability to unlock value at Freeline and deliver on the promise of its therapies and science to patients.” Dr. Hollowood continued, “I wish to thank Theresa for leading the Company through the successful completion of its initial public offering last year and the extraordinary challenges of the COVID-19 pandemic. We wish her well in her future endeavors.” “Freeline is at the forefront of gene therapy, leveraging a platform innovation engine that holds the potential to deliver functional cures to patients who suffer from debilitating diseases,” said Mr. Parini, CEO of Freeline. “I joined Freeline to deliver on the differentiated promise of our pipeline and technology, and am honored and excited to take the helm at this critical time for the Company.” Mr. Parini continued, “I see three immediate strategic priorities as we turn the page on a new chapter for the Company. First and foremost is our commitment to advancing our pipeline with urgency for patients. Our recent execution in the clinic is a testament to this commitment, and we remain on track to deliver all expected data and developmental milestones across our four clinical and pre-clinical stage gene therapy programs before year end. “Our second strategic priority is to drive increased focus, financial discipline and operational efficiency in our business. Based on a thorough review of our operations, we have identified initial savings to extend our cash runway by nearly two quarters into the first quarter of 2023, funding operations through multiple value-generating milestones. We will continue this work to optimize our business, operational and platform strategy. “Finally, our third priority is to unlock the full value in our proprietary scientific and platform technology. We are refreshing our scientific strategy to leverage our unique combination of manufacturing quality, capsid potency and protein engineering capabilities, which we believe can drive lower and safer doses for high therapeutic effect, into the next wave of pipeline programs. We plan to focus our research and platform efforts where our differentiated capabilities allow us to address unmet needs and create transformative treatments for patients.” Mr. Parini added, “We believe gene therapy holds tremendous promise. With our three strategic priorities in place, I look forward to building a world-class team and organization to realize the full potential of Freeline.” Key Pipeline and Operational Updates Hemophilia B On track to report up to four-year durability data from the Company’s Phase 1/2 dose-finding trial of FLT180a for the treatment of Hemophilia B by year end. Actively enrolling the ECLIPSE run-in study for the planned six-month Phase 1/2 dose-confirmation trial of FLT180a. On track to initiate clinical trial sites for the Phase 1/2 dose-confirmation trial by year end. The trial is designed to confirm the dose and immune management regimen for the planned Phase 3 pivotal trial of FLT180a. The Company is targeting full enrollment of the Phase 1/2 trial during the first half of 2022 and a six-month data readout by the end of 2022. Pursuing Accelerated Approval with the US Food & Drug Administration (“FDA”) using the surrogate endpoint of Factor IX (“FIX”) activity levels combined with demonstration of a positive correlation between 26-week FIX activity levels and 52-week Annualized Bleeding Rate (“ABR”), assuming robust data at 26 weeks. Targeting initiation of the planned Phase 3 pivotal trial targeted by mid-2023, with data readout and filing of a Biologics License Application (“BLA”) targeted by the end of 2024. Fabry Disease The first patient in the first and lowest-dose cohort of the Phase 1/2 dose-finding trial assessing the safety and efficacy of FLT190 for the treatment of Fabry disease in adult patients continues to show sustained, elevated level of plasma GLA activity over nearly two years post-dosing. The second patient was dosed in June, completing the first dose cohort. On track to dose additional patients at the next dose cohort level and report data by year end. Presented data at the American Society of Gene and Cell Therapy (“ASGCT”) Annual Meeting in May 2021 demonstrating GLA uptake and metabolic cross-correction in Fabry disease relevant cell lines. Gaucher Disease (Type 1) On track to initiate the Phase 1/2 dose-finding trial of FLT201 for the treatment of Gaucher disease Type 1 by year end. FDA Granted Orphan Drug Designation and the European Medicines Agency issued a positive opinion on Orphan Drug Designation for FLT201. Hemophilia A On track to complete preclinical IND/CTA enabling studies of FLT210 for the treatment of Hemophilia A by year end. Platform Technology Presented four posters at the ASGCT Annual Meeting in May 2021 detailing advancements in the Company’s 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. Corporate Announced leadership transformation with the appointment of Michael J. Parini as CEO. Mr. Parini assumed the role of CEO and Executive Director effective immediately, replacing former CEO Theresa Heggie. Since March of 2021, Mr. Parini served as the Company’s President and Chief Operating Officer (“COO”) and is an experienced public company biotechnology executive with previous leadership roles at both Vertex Pharmaceuticals, Inc. and Pfizer Inc. Announced that Alison Long, MD, PhD, SVP, Head of Clinical Development, will serve in the role of interim Chief Medical Officer (“CMO”) while an external search for a new CMO is conducted. Dr. Long has been instrumental in catalyzing the momentum in the Company’s clinical and pre-clinical programs. She is an established leader with 30 years of combined clinical and industry experience, including extensive gene therapy drug development experience previously leading clinical departments and programs at uniQure N.V. and, most recently, Spark Therapeutics, Inc., where she was Head of Clinical Research & Development. Q2 2021 Financial Highlights Cash Position: Cash and cash equivalents were $164.7 million as of June 30, 2021, as compared to $230.0 million as of December 31, 2020. Based on the Company’s revised operating plan, Freeline expects that its current level of cash and cash equivalents will enable the Company to fund its operating expenses into the first quarter of 2023. R&D Expenses: Research and development (“R&D”) expenses for the six months ended June 30, 2021 were $48.1 million, as compared to $29.4 million for the same period in 2020. The increase of $18.7 million was driven by 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 and further development of the Freeline platform. G&A Expenses: General and administrative (“G&A”) expenses for the six months ended June 30, 2021 were $24.6 million, as compared to $11.7 million for the same period in 2020. The increase of $12.9 million was driven primarily by an increase in personnel expenses, primarily due to an increase in headcount in corporate, legal, general and administrative functions to support the Company’s growth initiatives and public company requirements, as well as an increase in non-cash share-based compensation expense, primarily due to equity grants to employees related to the completion of the Series C financing and the IPO. As of June 30, 2021, the Company had 35,802,840 ordinary shares outstanding. About Michael J. Parini Michael Parini joined Freeline in March of 2021 to serve as the Company’s President and Chief Operating Officer. Before coming to Freeline, Mr. Parini was the Executive Vice President and Chief Administrative, Legal and Business Development Officer at Vertex Pharmaceuticals, Inc. from March 2020 until February 2021, among other roles he held in his over five years with the company. Prior to Vertex, Michael Parini spent over a decade at Pfizer Inc. serving in multiple leadership roles within the company's global legal team, including Senior Vice President and Associate General Counsel. 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 Type 1 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, including its review of strategy and operations; 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 and full enrollment 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 dose-finding clinical trial of FLT190 and data readouts from that trial, commencement of the Phase 1/2 dose-finding clinical trial of FLT201, and completion of pre-clinical IND/CTA-enabling studies of FLT210; 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; the recent departures of a number of executive officers of the Company, and the Company’s ability to fill open positions, implement an orderly transition process and retain key talent; 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 the Company’s Annual Report on Form 20-F for the fiscal year ended December 31, 2020 and in 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 . Contact David S. Arrington Vice President Investor Relations & Corporate Communications Freeline Therapeutics david.arrington@freeline.life +1 (646) 668 6947 FreelineTherapeuticsHoldings plc Unaudited Condensed ConsolidatedStatementsof Operations Data (in thousands of U.S. dollars, except per share data) For the Six Months Ended June 30, 2021 2020 OPERATING EXPENSES: Research and development $ 48,132 $ 29,445 General and administrative 24,615 11,663 Total operating expenses 72,747 41,108 LOSS FROM OPERATIONS: (72,747 ) (41,108 ) OTHER INCOME (EXPENSE) NET: Other income (expense), net (3,367 ) 862 Interest income, net 265 88 Benefit from R&D tax credit 1,050 6,894 Total other income (expense), net (2,052 ) 7,844 Loss before income taxes (74,799 ) (33,264 ) Income tax expense (16 ) — Net loss (74,815 ) (33,264 ) Net loss per share attributable to ordinary shareholders—basic and diluted $ (2.10 ) $ (3.51 ) Weighted average ordinary shares outstanding—basic and diluted 35,668,423 9,472,577 Freeline Therapeutics Holdings plc Unaudited Condensed Consolidated Balance Sheet Data (in thousands of U.S. dollars, except per share data) June 30 December 31, 2021 2020 ASSETS CURRENT ASSETS: Cash and cash equivalents $ 164,682 $ 229,974 Account receivable — 97 Prepaid expenses and other current assets 23,622 28,105 Total current assets 188,304 258,176 Property and equipment, net 10,050 8,608 Intangible assets, net 11 23 Other non-current assets 2,689 1,805 Total assets $ 201,054 $ 268,612 LIABILITIES, PREFERRED SHARES AND SHAREHOLDERS’ EQUITY CURRENT LIABILITIES: Accounts payable $ 4,550 $ 8,093 Accrued expenses and other current liabilities 10,873 10,719 Total current liabilities 15,423 18,812 Total liabilities 15,423 18,812 Commitments and contingencies SHAREHOLDERS’ EQUITY: Deferred shares 137 155 Additional paid-in capital 462,104 456,293 Accumulated other comprehensive loss 14,195 9,342 Accumulated deficit (290,805 ) (215,990 ) Total shareholders’ equity 185,631 249,800 TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY $ 201,054 $ 268,612