Gyroscope Therapeutics Announces Sanofi Investment of Up to $60 Million

Investment Further Validates Potential of Investigational Gene Therapy GT005 in Geographic Atrophy and Supports Ongoing Phase II Development Programme

LONDON–(BUSINESS WIRE)–Gyroscope Therapeutics Holdings plc (Gyroscope), a clinical-stage gene therapy company focused on diseases of the eye, today announced that Sanofi, a global biopharmaceutical company, has committed to invest up to USD $60.0 million (GBP £44.5 million) in equity in Gyroscope. Sanofi will invest $40.0 million in Gyroscope initially, at a premium to Gyroscope’s prior Series C financing, 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.

“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,” said Khurem Farooq, Chief Executive Officer, Gyroscope. “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’s ambition to develop gene therapies to treat geographic atrophy, a life-altering eye disease that has no approved treatments, aligns with our mission and our focus on pushing frontiers in genomic medicine,” said Christian Mueller, Vice President, Global Head of Genomic Medicine, Sanofi. “We are excited to be part of the Gyroscope story as they advance their promising investigational gene therapy, GT005, forward in clinical development.”

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 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.

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.

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.

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.¹ 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.² 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^3,4 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.

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¹ National Eye Institute. Age-Related Macular Degeneration. https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/age-related-macular-degeneration. Page last reviewed June 22, 2021. Accessed November 2, 2021.

² American Macular Degeneration Foundation. What is Macular Degeneration? https://www.macular.org/what-macular-degeneration. Accessed November 2, 2021.

³ Rudnicka, A. R., Jarrar, Z., Wormald, R., Cook, D. G., Fletcher, A., & Owen, C. G. (2012). Age and gender variations in age-related macular degeneration prevalence in populations of European ancestry: A meta-analysis. Ophthalmology, 119(3), 571–580. https://doi.org/10.1016/j.ophtha.2011.09.027
⁴ Wong, W. L., Su, X., Li, X., Cheung, C. M., Klein, R., Cheng, C.-Y., & Wong, T. Y. (2014). Global prevalence of age-related macular degeneration and disease burden projection for 2020 and 2040: A systematic review and meta-analysis. The Lancet Global Health, 2(2). https://doi.org/10.1016/s2214-109x(13)70145-1

Contacts

Charlotte Arnold

VP, Corporate Affairs

Gyroscope Therapeutics

[email protected]
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