Key shareholder support reinforces management’s focus on clinical execution, streamlining the organization and advancing the next stage of research and discovery
Freeline Therapeutics Holdings plc (Nasdaq: FRLN) (the “Company” or “Freeline”), today announced the closing of the registered direct offering of its American Depositary Shares (“ADSs”) announced on March 11, 2022. Freeline’s founding investor and majority shareholder Syncona Portfolio Limited, a subsidiary of Syncona Limited, and certain other existing shareholders purchased an aggregate of $26.1 million of Freeline’s ADSs. The proceeds will support the advancement of Freeline’s clinical stage programs and the extension of the Company’s scientific capabilities and platform technologies to additional disease areas.
“We are very pleased with the continuous support of our founding investor and other long-term shareholders and the strength this investment provides to our balance sheet. We remain highly focused on advancing our clinical programs in hemophilia B, Gaucher disease and Fabry disease efficiently through upcoming milestones on the path to pivotal Phase 3 studies,” commented Michael Parini, Chief Executive Officer of Freeline. “We continue to be disciplined in our investments and focused on maximizing efficiency throughout our business operations. Under the leadership of our newly appointed Chief Scientific Officer Henning Stennicke, we are developing a research and discovery strategy that leverages Freeline’s science and platform technologies in additional disease areas where we believe we can change the lives of people living with serious, debilitating disease.”
Chris Hollowood, Chief Investment Officer of Syncona Investment Management Limited and Chairman of Freeline, said: “We continue to work closely with our portfolio companies as they progress their programs to late-stage development. We are pleased to leverage our strategic balance sheet as we participate in this financing, which will allow the company to capitalize on its renewed momentum and significantly progress its clinical pipeline in hemophilia B, Fabry disease and Gaucher disease.”
As a result of this offering, 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 2023.
Freeline will report Q4 and full-year 2021 financial results and provide a more complete update on business highlights on March 31, 2022.
About Freeline Therapeutics Holdings plc
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 or dysfunctional 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, Fabry disease, and Gaucher disease Type 1. Freeline is headquartered in the UK and has operations in Germany and the US.
About Syncona Ltd
Syncona's purpose is to invest to extend and enhance human life. We do this by founding and building companies to deliver transformational treatments to patients in areas of high unmet need.
Our strategy is to found, build and fund companies around exceptional science to create a diversified portfolio of 15-20 globally leading healthcare businesses for the benefit of all our stakeholders. We focus on developing treatments for patients by working in close partnership with world-class academic founders and management teams. Our balance sheet underpins our strategy enabling us to take a long-term view as we look to improve the lives of patients with no or poor treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders.
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 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, statements regarding the use of the proceeds from the registered direct offering, the Company’s research and development strategy and the Company’s expectations regarding its use of cash and cash runway. 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. 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 prospectus supplement to be filed with the SEC, including the documents incorporated by reference therein, which include the Company’s Annual Report 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 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 SEC. You may review these documents by visiting EDGAR on the SEC website at www.sec.gov.
Arne Naeveke, PhD
Vice President, Head of Corporate Communications
+1 617 312 2521