REG - Syncona Limited - Gyroscope Announces Sanofi Equity Investment

SynconaAnnouncement

08/11/2021 14:10

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RNS Number : 6577R  Syncona Limited  08 November 2021

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
(https://clinicaltrials.gov/ct2/show/NCT03846193?term=GT005&cond=AMD&draw=2&rank=1)
]: 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
(https://clinicaltrials.gov/ct2/show/NCT04437368?term=geographic+atrophy%2C+GT005&cond=Macular+Degeneration&draw=2&rank=1#contacts)
] and HORIZON [NCT04566445
(https://clinicaltrials.gov/ct2/show/NCT04566445?term=GT005&draw=2&rank=1)
]: 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/
(https://www.gyroscopetx.com/) and follow us on Twitter (@GyroscopeTx
(https://twitter.com/GyroscopeTx) ) and on LinkedIn
(https://www.linkedin.com/organization-guest/company/gyroscope-therapeutics) .

 

 

 

 

 

 1  FX rates as at end of day 05/11/21

 2  See footnote 1

 3  Excluding the remaining $20m commitment from Sanofi

 4 As at 30 September 2021; Syncona holding will continue to be valued at
Price of Recent Investment in line with the Series C financing round and IPEV
guidelines

 5  National Eye Institute. Age-Related Macular Degeneration.
https://www.nei.nih.gov/learn-about-eye-health/eye-conditions-and-diseases/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 September 28, 2021.

 6  American Macular Degeneration Foundation. What is Macular Degeneration?
https://www.macular.org/what-macular-degeneration
(https://www.macular.org/what-macular-degeneration) . Accessed September 28,
2021.

 7  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
(https://doi.org/10.1016/j.ophtha.2011.09.027)

 8  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

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