Freeline Announces $26.1 Million Direct Recording

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LONDON, March 11, 2022 (GLOBE NEWSWIRE) — Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), a clinical-stage biotechnology company developing AAV-mediated transformative gene therapies for people with inherited systemic debilitating conditions, today announced that it has entered into a definitive agreement with Freeline’s majority shareholder, Syncona Portfolio Limited, a subsidiary of Syncona Limited, and certain other existing shareholders to purchase a total of 26 .1 million of its American Depositary Shares (“ADS”), each representing one common share of the Company, at a price of $1.05 per ADS, pursuant to a registered direct offer.

The offering is expected to close on or about March 15, 2022, subject to the satisfaction of customary closing conditions.

Freeline intends to use the net proceeds of this offering to fund activities related to the continued development of its product candidates and gene therapy platform and for other general corporate purposes. Following this offering, the Company expects its level of cash and cash equivalents to fund its operating expenses through the third quarter of 2023. The Company has engaged Wedbush Securities Inc. as financial advisor in connection with the offer. .

The securities described above will be offered by the Company pursuant to an effective “pending” registration statement on Form F-3 (File No. 333-259444) previously filed with the Securities and Exchange Commission (the “SEC”). ) on September 10, 2021 and declared effective by the SEC on September 22, 2021. The securities may only be offered by means of a written prospectus and prospectus supplement which form part of the registration statement. The Prospectus Supplement and the accompanying Offering Prospectus contain important information relating to the ADSs. The Prospectus Supplement will be filed with the SEC and will be available on the SEC’s website at http://www.sec.gov, or may be obtained, when available, by contacting Freeline Therapeutics Holdings plc, c/o Freeline Therapeutics, Inc., Attn: Investor Relations, 915 Broadway, Suite 1005, New York, New York 10010, or by email at [email protected]

This press release does not constitute an offer to sell or the solicitation of an offer to buy, and there will be no sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful. prior to registration or qualification. under the securities laws of such state or territory.

In any member state of the European Economic Area (the “EEA”), this announcement and any offer are only for distribution to and intended for persons who are “qualified investors” (“Qualified Investors”) within the meaning of Regulation (EU) 2017./1129, as amended. In the United Kingdom, this announcement and any offer is only for distribution and directed to qualified investors within the meaning of Regulation (EU) 2017/1129, as it forms part of national law in the United Kingdom under the Union European (Withdrawal) Act 2018 who (i) have professional experience in matters relating to investments falling within section 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the “ Ordinance”), (ii) are high net worth entities that fall under section 49(2)(a) to (d) of the Ordinance, or (iii) are persons to whom an invitation or inducement to engage in investment activity (within the meaning of section 21 of the Services and Markets Act 2000) in connection with the issue or sale of securities may otherwise lawfully be disclosed or be disclosed (all such persons being referred to as “data subjects”).

This announcement should not be acted upon or relied upon (i) in the United Kingdom, by persons who are not data subjects, and (ii) in any Member State of the EEA, by persons who are not not Qualified Investors. Any investment or investment activity to which this announcement relates is available to and will only be engaged in with (i) in the UK, relevant persons, and (ii) in any member state of the EEA, qualified investors.

About Freeline Therapeutics Holdings plc

Freeline is a clinical-stage biotechnology company developing transformative systemic gene therapies mediated by adeno-associated virus (“AAV”). The company is dedicated to improving the lives of patients through innovative, timely treatments that provide functional cures for debilitating inherited systemic 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 in the patient’s blood circulation. The Company’s integrated gene therapy platform includes in-house research, clinical development, manufacturing and commercialization capabilities. The company has clinical programs in haemophilia B, Fabry disease and Gaucher disease type 1. Freeline is headquartered in the UK and has operations in Germany and the United States.

Forward-looking statements

This press release may contain 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 opinions, expectations, beliefs, plans , objectives, assumptions or projections of the Company. regarding future events or future results, as opposed to statements that reflect historical facts. In some cases, you can identify these forward-looking statements by terms such as “anticipate”, “intend”, “believe”, “estimate”, “plan”, “seek”, “project” or “will”. expect”, “could”, “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 numerous risks and uncertainties, including the satisfaction of customary closing conditions and the consummation of the Offer; recurring operating losses of the Company; uncertainties inherent in the research and development of the Company’s product candidates, including statements regarding the timing of the initiation, completion and results of studies or clinical trials and related preparatory work and regulatory review, regulatory submission dates, regulatory approval dates and/or launch dates, and risks associated with preclinical and clinical data, including the possibility of new adverse preclinical, clinical or safety data and additional analyzes 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 senior executives from the Company and the Company’s ability to fill vacancies, 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 anticipated schedule; the possibility that a pandemic, epidemic or outbreak of infectious diseases in the United States, the United Kingdom or the EU, including the COVID-19 pandemic, will disrupt and delay the company’s clinical trial pipeline Society ; the Company’s inability to demonstrate the safety and efficacy of its product candidates; the fact that results obtained in earlier stage clinical trials may not be indicative of the results of 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 possess other properties that may delay or prevent their regulatory approval or limit their commercial potential; the Company’s ability to obtain and maintain regulatory approval for its product candidates; the Company’s limited manufacturing experience, which could lead to 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 its inability to capitalize on programs or product candidates. These risks and uncertainties may cause 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 materialize. Should known or unknown risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results could vary materially from past results and from those anticipated, estimated or projected. Investors are cautioned not to place undue reliance on forward-looking statements. A further list and description of risks, uncertainties and other matters may be found in the Company’s prospectus supplement to be filed with the SEC, including the documents incorporated by reference therein, which include the annual report of the Company on Form 20-F filed with the SEC on March 31, 2021 and the Company’s other periodic reports filed with the SEC. Many of these risks are beyond the Company’s control and could cause its actual results to differ materially from those expected to occur. The forward-looking statements included in this press release speak only as of the date hereof. The Company does not undertake, and specifically disclaims, any obligation to update these statements or to publicly announce the results of any revisions to these statements to reflect future events or developments, except as required by law. For further information, please refer to the Company’s reports and documents filed with the SEC. You can view these documents by visiting EDGAR on the SEC’s website at www.sec.gov.

IR contact:

[email protected]

Media Contact:

Arne Naeveke, PhD
Vice President, Head of Corporate Communications
[email protected]
+1 617 312 2521

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