8 November 2021

Gyroscope Announces Sanofi Equity Investment of up to $60 Million

·    Sanofi has committed to invest up to $60.0 million (£44.5[1] million) in equity of Gyroscope; $40.0 million initial investment with $20.0 million contingent on a future qualifying investment round

·   Investment further validates the potential of Gyroscope's gene therapy GT005 for the treatment of Geographic Atrophy, one of the world's leading causes of blindness, and supports its ongoing Phase II development programmes

Syncona Ltd, a leading healthcare company focused on founding, building and funding a portfolio of global leaders in life science, today announced Sanofi, a global biopharmaceutical company, has committed to invest up to $60.0 million (£44.5 million)[2] in equity of Gyroscope Therapeutics Holdings plc ("Gyroscope"). Sanofi will invest $40.0 million in Gyroscope initially and the remaining $20.0 million will be invested contingent on a future qualifying investment round and subject to the satisfaction of certain closing conditions.

Under the terms of the agreement, a Sanofi R&D executive will join the Gyroscope Clinical Advisory Board to advise on matters related to the development of GT005, Gyroscope's lead investigational gene therapy being developed for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Additionally, Gyroscope has granted Sanofi an exclusive right of first refusal on certain potential future transactions for GT005 in select geographies.

Following the financing, Syncona's ownership position will be 49 per cent[3]. Syncona's holding value will be £153.5 million[4].

Chris Hollowood, Chief Investment Officer of Syncona Investment Management Limited and Chairman of Gyroscope, said: "We are delighted that Sanofi is investing alongside us in Gyroscope. Gyroscope has made significant progress since its foundation in 2016, stewarded by a world-class management team. It has reported encouraging data from its Phase I/II study with its investigational gene therapy, GT005, which is now being evaluated in Phase II clinical trials for the treatment of geographic atrophy. We are excited about the potential of the therapies Gyroscope is seeking to develop for patients in an area where there are no treatment options. Today's investment by one of the globally leading biopharmaceutical firms, Sanofi, further validates the potential of these therapies and the opportunity that lies ahead, providing the business with additional financing to continue to execute its clinical development."  

Khurem Farooq, Chief Executive Officer, Gyroscope, said: "We are thrilled to welcome Sanofi onboard as an investor in Gyroscope. Their investment is a testament to the promise of our science and gene therapy programmes to make a difference for people with serious eye diseases. We believe our lead investigational gene therapy, GT005, has the potential to be the first gene therapy for geographic atrophy, a devastating cause of vision loss for more than 5 million people globally, and were pleased to recently announce additional encouraging data from our ongoing Phase I/II FOCUS clinical trial."

Gyroscope plans to use proceeds from this investment to support funding of ongoing clinical trials of GT005 in GA. GT005 has been granted Fast Track designation by the U.S. Food and Drug Administration and is being evaluated in Phase II clinical trials.

[ENDS]

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.

Enquiries

Syncona Ltd

Annabel Clay / Fergus Witt

Tel: +44 (0) 20 3981 7940

FTI Consulting

Ben Atwell / Natalie Garland-Collins / Tim Stamper

Tel: +44 (0) 20 3727 1000

About Syncona

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 dynamic 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 few treatment options, build sustainable life science companies and deliver strong risk-adjusted returns to shareholders.

About GT005

GT005 is an investigational AAV2-based gene therapy for GA secondary to AMD that is designed to be a one-time treatment delivered under the retina. GT005 aims to restore balance to an overactive complement system, a part of the immune system, by increasing production of the Complement Factor I (CFI) protein, which regulates the activity of the complement system. Complement overactivation can lead to inflammation that damages healthy tissues, and it has been strongly correlated with the development and progression of AMD. It is believed that increasing CFI production could reduce inflammation, with the goal of preserving a person's eyesight.

GT005 is being evaluated in several clinical trials, including:

·      FOCUS [NCT03846193]: Phase I/II open-label clinical trial evaluating the safety and dose response of three doses of GT005 in people with GA secondary to AMD.

·      EXPLORE [NCT04437368] and HORIZON [NCT04566445]: Phase II, multicentre, randomised, controlled, assessor-outcomes masked trials evaluating the safety and effectiveness of GT005. EXPLORE is enrolling people with GA secondary to AMD who have rare variants in their CFI gene associated with low levels of CFI protein in the blood. HORIZON is enrolling a broader group of people who have GA secondary to AMD.

About Dry Age-Related Macular Degeneration (AMD) and Geographic Atrophy (GA)

Dry AMD is a leading cause of permanent vision loss in people over the age of 55 and is a devastating diagnosis.^[5] There are currently no approved treatments for dry AMD, which is the most common form of AMD, impacting approximately 85-90% of people with AMD.^[6] As dry AMD advances, it leads to GA, an irreversible degeneration of retinal cells, causing a gradual and permanent loss of central vision. This disease affects more than 5 million people globally[7]^,[8] and can severely impact a person's daily life as they lose the ability to drive, read and even see the faces of loved ones.

About Gyroscope: Vision for Life

Gyroscope Therapeutics is a clinical-stage gene therapy company developing gene therapy beyond rare disease to treat diseases of the eye that cause vision loss and blindness. Our lead investigational gene therapy, GT005, is currently being evaluated in Phase II clinical trials for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD), a leading cause of blindness. GT005 has received Fast Track designation from the U.S. Food and Drug Administration for the treatment of people with GA.

Supported by leading life sciences investors and biopharmaceutical companies, Gyroscope has built a global organisation combining discovery, research, drug development, a manufacturing platform and surgical delivery capabilities. Headquartered in London with locations in Philadelphia and San Francisco, our mission is to preserve sight and fight the devastating impact of blindness.

For more information visit: https://www.gyroscopetx.com/ and follow us on Twitter (@GyroscopeTx) and on LinkedIn.