Syncona Regulatory News (SYNC)

Syncona Limited

SYNCONA MAKES FURTHER $80 MILLION COMMITMENT TO FREELINE

19 December 2019

·; $80.0 million (£61.1 million)[1] commitment to Freeline in a Series C financing, a leading gene therapy company focused on liver expression for a range of chronic systemic diseases

·; Freeline has a pipeline of four disclosed programmes, two of which are clinical stage, and is developing a next-generation gene therapy using a proprietary, novel capsid and best-in-class manufacturing platform

·; Freeline is valued at cost[2] and held at £149.1 million following the first tranche of $40.0 million (£30.6 million) of the Series C investment

Syncona Ltd, a leading healthcare company focused on founding, building and funding global leaders in life science, today announces that it has made a $80.0 million commitment in a Series C financing by Freeline. Syncona has funded the first tranche of this commitment, amounting to $40.0 million (£30.6 million)[3]. Syncona has a 79 per cent fully diluted ownership stake at the point full current commitments are invested.

Freeline is progressing FLT180a, its lead programme in Haemophilia B, through clinical development. The company has reported that the first two patients in its ongoing Phase 1/2 trial who were treated with the lowest dose[4] have shown that Factor IX (FIX) activity remains stable and consistent at 40.5±4.5% through weeks 66 and 74 post administration. The normal range of FIX activity in the general population's blood is between 50 per cent and 150 per cent. Freeline uses a novel capsid which is capable of driving high protein expression. The company continues to enrol Haemophilia B patients as part of its dose-ranging trial. Freeline is currently seeking to identify the optimal dosing regimen to deliver FIX activity consistently in the normal range for all patients and will report further data in this financial year (by March 2020).

Freeline has also recently dosed the first patient in its second programme in Fabry Disease, which it is estimated affects one in every 40,000[5] people. This programme is the first clinical stage AAV gene therapy study targeting Fabry Disease globally. The company also has disclosed pre-clinical programmes targeting Gaucher Disease and Haemophilia A, which are part of a broad pipeline of systemic disorders, where high protein expression is crucial to providing functional cures for patients.

Syncona's first tranche of $40.0 million will enable the company to expand its team, continue to develop its robust manufacturing platform including commercial supply capability, generate further data in its clinical programmes for Haemophilia B and Fabry Disease and continue to progress its pipeline.

Chris Hollowood, Chief Investment Officer of Syncona and Executive Chairman of Freeline, said: "Freeline has developed a high-quality gene therapy platform with a novel capsid capable of driving high expression levels to treat systemic diseases. We are encouraged by the potential product profile in our lead programme in Haemophilia B and believe Freeline has the opportunity to achieve functional cures for patients across a broad pipeline of systemic diseases. We are continuing with dose optimisation and remain on track to provide a clinical data update by financial year end.

"This financing demonstrates Syncona's differentiated approach of funding our companies over the long term. Our deep capital base enables us to continue to strongly back our companies as they progress through the development cycle and navigate clinical and operational risks. We look forward to continuing to work in close partnership with Freeline."

In line with Syncona's valuation policy, we continue to hold our investment in Freeline at cost[6] until material clinical data is generated, or a third-party financing or other factor occurs, that indicates that cost[7] is no longer the appropriate measure of fair value. 

[ENDS]

Enquiries

Syncona Ltd

Siobhan Weaver / Annabel Clay

Tel: +44 (0) 20 3981 7940

FTI Consulting

Ben Atwell / Natalie Garland-Collins

Tel: +44 (0) 20 3727 1000

Copies of this press release and other corporate information can be found on the company website at: www.synconaltd.com

Forward-looking statements - this announcement contains certain forward-looking statements with respect to the portfolio of investments of Syncona Limited. These statements and forecasts involve risk and uncertainty because they relate to events and depend upon circumstances that may or may not occur in the future. There are a number of factors that could cause actual results or developments to differ materially from those expressed or implied by these forward-looking statements. In particular, many companies in the Syncona Limited portfolio are conducting scientific research and clinical trials where the outcome is inherently uncertain and there is significant risk of negative results or adverse events arising. In addition, many companies in the Syncona Limited portfolio have yet to commercialise a product and their ability to do so may be affected by operational, commercial and other risks.

About Syncona

Syncona is a leading FTSE250 healthcare company focused on founding, building and funding a portfolio of global leaders in life science. Our vision is to build a sustainable, diverse portfolio of 15 - 20 companies focused on delivering transformational treatments to patients in truly innovative areas of healthcare, through which we are seeking to deliver strong risk-adjusted returns for shareholders.

We seek to partner with the best, brightest and most ambitious minds in science to build globally competitive businesses. We take a long-term view, underpinned by a strategic capital base which provides us with control and flexibility over the management of our portfolio. We focus on delivering dramatic efficacy for patients in areas of high unmet need.