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  • AM Best Revises Outlooks to Positive for CICA Re

    LONDON–(BUSINESS WIRE)–AM Best has revised the outlooks to positive from stable and affirmed the Financial Strength Rating of B (Fair) and the Long-Term Issuer Credit Rating of “bb+” of Compagnie Commune de Réassurance des Etats Membres de la Conférence Interafricaine des Marchés d’Assurances (CICA Re) (Togo).

    The Credit Ratings (ratings) reflect CICA Re’s balance sheet strength, which AM Best categorises as very strong, as well as its adequate operating performance, neutral business profile and weak enterprise risk management (ERM).

    The revision of the outlooks to positive follows the strengthening of CICA Re’s ERM framework and capabilities over recent years, during which the company carried out a detailed framework review, utilising internal resources and third-party risk consultants. Whilst CICA Re’s ERM remains at an early stage of development, AM Best expects the improvements to continue in the near term, notably as the company further formalises and embeds its ERM framework.

    CICA Re’s balance sheet strength is underpinned by its risk-adjusted capitalisation, which was at the strongest level at year-end 2019, as measured by Best’s Capital Adequacy Ratio (BCAR). The introduction of compulsory cessions to CICA Re on direct insurance business in the Conférence Interafricaine des Marchés d’Assurances (CIMA) region, effective since 2020, has resulted in a significant increase in the company’s underwriting risks, with net written premium projected to have increased by approximately 40% in 2020. However, CICA Re benefits from good financial flexibility, demonstrated through its successful capital raise of CFAF 20 billion (USD 36.8 million) from existing shareholders and new investors over the past two years, and AM Best expects CICA Re’s prospective risk-adjusted capitalisation to remain comfortably in excess of the level required for the strongest assessment. Partially offsetting balance sheet strength factors include high levels of receivables and the limited quality of assets, which have the potential to introduce volatility to the company’s solvency position.

    CICA Re has a track record of adequate operating performance, with a five-year (2015-2019) weighted average operating ratio of 89.9%, supported by good underwriting results and stable investment income. The company reported a net profit of CFAF 5.1 billion (USD 8.7 million) in 2019, up from CFAF 4.6 billion (USD 8.0 million) in the previous year, driven by higher non-life insurance margins. AM Best expects net earnings to increase from 2020 onward, reflecting the increase in compulsory cessions in the region, provided the underlying profitability of insurance markets in the CIMA region remains good.

    CICA Re maintains a good market position within the CIMA region, where it benefits from legal compulsory cessions on reinsurance business. In addition, the company also has a portfolio of open-market business originated from the CIMA region and across Africa, Asia and the Middle East, which AM Best expects to account for approximately half of total premium income going forward. Whilst the introduction of compulsory reinsurance cessions on direct business in 2020 enhanced CICA Re’s profile in the region, the business profile assessment remains constrained by the company’s modest scale by international standards, owing to the small size of the CIMA zone, and its role as a largely following reinsurer.

    This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

    AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

    Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

    Contacts

    Alex Rafferty, ACA

    Associate Director, Analytics

    +44 20 7397 0312
    alex.rafferty@ambest.com

    Ghislain Le Cam, CFA, FRM
    Director, Analytics
    +44 20 7397 0268
    ghislain.lecam@ambest.com

    Christopher Sharkey
    Manager, Public Relations
    +1 908 439 2200, ext. 5159
    christopher.sharkey@ambest.com

    Jim Peavy
    Director, Communications
    +1 908 439 2200, ext. 5644
    james.peavy@ambest.com

  • AM Best Revises Outlooks to Positive for CICA Re

    LONDON–(BUSINESS WIRE)–AM Best has revised the outlooks to positive from stable and affirmed the Financial Strength Rating of B (Fair) and the Long-Term Issuer Credit Rating of “bb+” of Compagnie Commune de Réassurance des Etats Membres de la Conférence Interafricaine des Marchés d’Assurances (CICA Re) (Togo).

    The Credit Ratings (ratings) reflect CICA Re’s balance sheet strength, which AM Best categorises as very strong, as well as its adequate operating performance, neutral business profile and weak enterprise risk management (ERM).

    The revision of the outlooks to positive follows the strengthening of CICA Re’s ERM framework and capabilities over recent years, during which the company carried out a detailed framework review, utilising internal resources and third-party risk consultants. Whilst CICA Re’s ERM remains at an early stage of development, AM Best expects the improvements to continue in the near term, notably as the company further formalises and embeds its ERM framework.

    CICA Re’s balance sheet strength is underpinned by its risk-adjusted capitalisation, which was at the strongest level at year-end 2019, as measured by Best’s Capital Adequacy Ratio (BCAR). The introduction of compulsory cessions to CICA Re on direct insurance business in the Conférence Interafricaine des Marchés d’Assurances (CIMA) region, effective since 2020, has resulted in a significant increase in the company’s underwriting risks, with net written premium projected to have increased by approximately 40% in 2020. However, CICA Re benefits from good financial flexibility, demonstrated through its successful capital raise of CFAF 20 billion (USD 36.8 million) from existing shareholders and new investors over the past two years, and AM Best expects CICA Re’s prospective risk-adjusted capitalisation to remain comfortably in excess of the level required for the strongest assessment. Partially offsetting balance sheet strength factors include high levels of receivables and the limited quality of assets, which have the potential to introduce volatility to the company’s solvency position.

    CICA Re has a track record of adequate operating performance, with a five-year (2015-2019) weighted average operating ratio of 89.9%, supported by good underwriting results and stable investment income. The company reported a net profit of CFAF 5.1 billion (USD 8.7 million) in 2019, up from CFAF 4.6 billion (USD 8.0 million) in the previous year, driven by higher non-life insurance margins. AM Best expects net earnings to increase from 2020 onward, reflecting the increase in compulsory cessions in the region, provided the underlying profitability of insurance markets in the CIMA region remains good.

    CICA Re maintains a good market position within the CIMA region, where it benefits from legal compulsory cessions on reinsurance business. In addition, the company also has a portfolio of open-market business originated from the CIMA region and across Africa, Asia and the Middle East, which AM Best expects to account for approximately half of total premium income going forward. Whilst the introduction of compulsory reinsurance cessions on direct business in 2020 enhanced CICA Re’s profile in the region, the business profile assessment remains constrained by the company’s modest scale by international standards, owing to the small size of the CIMA zone, and its role as a largely following reinsurer.

    This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

    AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

    Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

    Contacts

    Alex Rafferty, ACA

    Associate Director, Analytics

    +44 20 7397 0312
    alex.rafferty@ambest.com

    Ghislain Le Cam, CFA, FRM
    Director, Analytics
    +44 20 7397 0268
    ghislain.lecam@ambest.com

    Christopher Sharkey
    Manager, Public Relations
    +1 908 439 2200, ext. 5159
    christopher.sharkey@ambest.com

    Jim Peavy
    Director, Communications
    +1 908 439 2200, ext. 5644
    james.peavy@ambest.com

  • AM Best Affirms Credit Ratings of Halyk-Life, JSC

    LONDON–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating of B+ (Good) and the Long-Term Issuer Credit Rating of “bbb-” of Halyk-Life, Life Insurance Subsidiary Company of the Halyk Bank of Kazakhstan, JSC (Halyk-Life) (Kazakhstan). Halyk-Life is a wholly owned subsidiary of JSC Halyk Bank, a leading retail bank in Kazakhstan. The outlook of these Credit Ratings (ratings) is positive.

    The ratings reflect Halyk-Life’s balance sheet strength, which AM Best categorises as very strong, as well as its adequate operating performance, limited business profile and marginal enterprise risk management.

    The positive outlooks reflect improvements in Halyk-Life’s operating performance metrics observed in recent years.

    Halyk-Life’s balance sheet strength is underpinned by its risk-adjusted capitalisation that is categorised as strongest, as measured by Best’s Capital Adequacy Ratio (BCAR), based on unaudited 2020 year-end regulatory returns. AM Best expects the company’s prospective BCAR to remain at the strongest level, helped by solid operating results and a dividend policy that allows for sufficient earnings retention to support its growth plans. Halyk-Life’s investment portfolio is relatively conservative by asset class, with fixed-income securities, cash and bank deposits accounting for over 90% of its investments as at year-end 2020. A partially offsetting factor is the sizeable asset-liability duration mismatch maintained by the company, which could affect its balance sheet strength over the longer term. The ratings also factor in Halyk-Life’s exposure to the high levels of economic, political and financial system risk associated with operating predominantly in Kazakhstan.

    Halyk-Life has reported improved operating performance in recent years, supported by economies of scale that followed the merger in 2018 of sister insurer, Kazkommerts Life Insurance Company, JSC, and good investment returns, although the latter should be viewed in the context of the high inflationary environment in Kazakhstan. In 2020, the company reported a return on equity of approximately 37% (2019: approximately 33%). AM Best expects Halyk-Life to build a track record of strong operating profitability prospectively, underpinned by the growth of its life insurance book and the actions taken to control its operating expenses. Nonetheless, future results could be challenged by the intense competition in the Kazakh life insurance market and the high regulatory risk in the country.

    Halyk-Life is a leading insurer in Kazakhstan’s life insurance market, with an estimated market share of 29%, based on 2020 gross written premium. However, Halyk-Life’s operations are limited to its domestic insurance market, which is small by international standards. In addition, the company remains highly dependent on third-party distribution channels, especially for its credit life business.

    This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

    AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

    Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

    Contacts

    Todor Kitin
    Financial Analyst
    +44 20 7397 0335
    todor.kitin@ambest.com

    Valeria Ermakova
    Associate Director, Analytics
    +44 20 7397 0269
    valeria.ermakova@ambest.com

    Christopher Sharkey
    Manager, Public Relations
    +1 908 439 2200, ext. 5159
    christopher.sharkey@ambest.com

    Jim Peavy
    Director, Communications
    +1 908 439 2200, ext. 5644
    james.peavy@ambest.com

  • AM Best Affirms Credit Ratings of Halyk-Life, JSC

    LONDON–(BUSINESS WIRE)–AM Best has affirmed the Financial Strength Rating of B+ (Good) and the Long-Term Issuer Credit Rating of “bbb-” of Halyk-Life, Life Insurance Subsidiary Company of the Halyk Bank of Kazakhstan, JSC (Halyk-Life) (Kazakhstan). Halyk-Life is a wholly owned subsidiary of JSC Halyk Bank, a leading retail bank in Kazakhstan. The outlook of these Credit Ratings (ratings) is positive.

    The ratings reflect Halyk-Life’s balance sheet strength, which AM Best categorises as very strong, as well as its adequate operating performance, limited business profile and marginal enterprise risk management.

    The positive outlooks reflect improvements in Halyk-Life’s operating performance metrics observed in recent years.

    Halyk-Life’s balance sheet strength is underpinned by its risk-adjusted capitalisation that is categorised as strongest, as measured by Best’s Capital Adequacy Ratio (BCAR), based on unaudited 2020 year-end regulatory returns. AM Best expects the company’s prospective BCAR to remain at the strongest level, helped by solid operating results and a dividend policy that allows for sufficient earnings retention to support its growth plans. Halyk-Life’s investment portfolio is relatively conservative by asset class, with fixed-income securities, cash and bank deposits accounting for over 90% of its investments as at year-end 2020. A partially offsetting factor is the sizeable asset-liability duration mismatch maintained by the company, which could affect its balance sheet strength over the longer term. The ratings also factor in Halyk-Life’s exposure to the high levels of economic, political and financial system risk associated with operating predominantly in Kazakhstan.

    Halyk-Life has reported improved operating performance in recent years, supported by economies of scale that followed the merger in 2018 of sister insurer, Kazkommerts Life Insurance Company, JSC, and good investment returns, although the latter should be viewed in the context of the high inflationary environment in Kazakhstan. In 2020, the company reported a return on equity of approximately 37% (2019: approximately 33%). AM Best expects Halyk-Life to build a track record of strong operating profitability prospectively, underpinned by the growth of its life insurance book and the actions taken to control its operating expenses. Nonetheless, future results could be challenged by the intense competition in the Kazakh life insurance market and the high regulatory risk in the country.

    Halyk-Life is a leading insurer in Kazakhstan’s life insurance market, with an estimated market share of 29%, based on 2020 gross written premium. However, Halyk-Life’s operations are limited to its domestic insurance market, which is small by international standards. In addition, the company remains highly dependent on third-party distribution channels, especially for its credit life business.

    This press release relates to Credit Ratings that have been published on AM Best’s website. For all rating information relating to the release and pertinent disclosures, including details of the office responsible for issuing each of the individual ratings referenced in this release, please see AM Best’s Recent Rating Activity web page. For additional information regarding the use and limitations of Credit Rating opinions, please view Guide to Best’s Credit Ratings. For information on the proper media use of Best’s Credit Ratings and AM Best press releases, please view Guide for Media – Proper Use of Best’s Credit Ratings and AM Best Rating Action Press Releases.

    AM Best is a global credit rating agency, news publisher and data analytics provider specialising in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

    Copyright © 2021 by A.M. Best Rating Services, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

    Contacts

    Todor Kitin
    Financial Analyst
    +44 20 7397 0335
    todor.kitin@ambest.com

    Valeria Ermakova
    Associate Director, Analytics
    +44 20 7397 0269
    valeria.ermakova@ambest.com

    Christopher Sharkey
    Manager, Public Relations
    +1 908 439 2200, ext. 5159
    christopher.sharkey@ambest.com

    Jim Peavy
    Director, Communications
    +1 908 439 2200, ext. 5644
    james.peavy@ambest.com

  • United Kingdom Used Car Finance Market Insight Report 2021 – ResearchAndMarkets.com

    DUBLIN–(BUSINESS WIRE)–The “UK Used Car Finance: Market Insight Report 2021” report has been added to ResearchAndMarkets.com’s offering.

    The report focuses on the UK market for secured consumer finance for used/second-hand cars.

    • It also includes agreements for used motorcycles, vans and leisure vehicles (e.g. campervans) however cars represent over 95% of the relevant consumer market.
    • Secured loans are defined as those where the ownership of the vehicle rests with the lender during the life of the agreement.
    • The report excludes unsecured personal loans that some consumers may use when buying a car, which the publisher believes is now a relatively minor form of car finance.
    • It includes agreements for vehicles that might be used for business purposes by individuals but are purchased by consumers rather than the businesses they run.

    The report:

    • Describes the overall used vehicle market size and historical growth rates.
    • Profiles 25 largest used vehicle loan providers.
    • Describes the role of brokers, including firms working with vehicle dealers and those dealing direct with consumers.
    • Reviews drivers of used vehicle loan growth, setting out historical trends and available forecasts.
    • Provides the forecast for the market to 2021, supported by evidence from market drivers and industry interviews.

    Key Topics Covered:

    About this report

    • What does the report contain?
    • What are the objectives of this report?
    • Who is it useful for?
    • What are the sources and methodology?

    Summary

    • The used car finance market

    Market size and growth

    • Outlook

    About the Publisher

    • Company background
    • Consulting services
    • Commercial/operational due diligence
    • Custom market analysis
    • Primary research
    • Growth strategy
    • Related research

    List of Charts and Tables

    • Used car finance market
    • Definition of the market
    • Types of finance offered to purchase cars
    • Hire Purchase
    • Personal Contract Plan (PCP)
    • Lease
    • Alternative products
    • Non-POS car loan
    • Personal loan
    • Mortgage further advance
    • Credit Card
    • Types of customers

    Market size and growth

    • UK car market
    • Dealer sales
    • Franchised dealers
    • Independent dealers
    • Other vehicle distributors
    • Motor finance penetration
    • Motor finance volumes
    • Non-prime lending

    Market Drivers

    • Regulatory landscape
    • FCA authorisation
    • Regulatory requirements
    • Recent regulatory developments
    • UK Economic performance
    • Consumer borrowing
    • Ability to service borrowing
    • Wages
    • Source: Bank of England Financial Stability Report November 2017
    • Other market drivers

    Competitive landscape

    • Overview
    • Success factors in dealer POS finance
    • Market size and share
    • Sub-Prime sector
    • Split by channel

    Major lenders

    • Barclays Partner Finance
    • Black Horse (Lloyds Banking Group)
    • Close Brothers Motor Finance
    • Hitachi Capital
    • MotoNovo
    • Santander UK plc

    Other lenders

    • 1st Stop Car Finance
    • Advantage Finance
    • Alphera
    • Billing Finance
    • Blue Motor
    • First Response
    • JBR Capital
    • Mallard Vehicle Finance
    • Marsh
    • Moneybarn
    • Moneyway
    • NIIB Group
    • Oodle Financial Services
    • Paragon
    • Private & Commercial
    • Raphaels Bank
    • Startline
    • The Car Finance Company
    • Other funders
    • Admiral Loans
    • Car Finance Limited
    • Ratesetter
    • Car dealer finance brokers
    • Auto Union Finance
    • Creditas
    • DSG Financial Services
    • Eurodrive
    • Evolution Funding
    • Jigsaw Finance
    • Mann Island Finance
    • Motion Finance
    • Whichdeal Limited

    For more information about this report visit https://www.researchandmarkets.com/r/pehqza

    Contacts

    ResearchAndMarkets.com

    Laura Wood, Senior Press Manager

    press@researchandmarkets.com

    For E.S.T Office Hours Call 1-917-300-0470

    For U.S./CAN Toll Free Call 1-800-526-8630

    For GMT Office Hours Call +353-1-416-8900

  • United Kingdom Used Car Finance Market Insight Report 2021 – ResearchAndMarkets.com

    DUBLIN–(BUSINESS WIRE)–The “UK Used Car Finance: Market Insight Report 2021” report has been added to ResearchAndMarkets.com’s offering.

    The report focuses on the UK market for secured consumer finance for used/second-hand cars.

    • It also includes agreements for used motorcycles, vans and leisure vehicles (e.g. campervans) however cars represent over 95% of the relevant consumer market.
    • Secured loans are defined as those where the ownership of the vehicle rests with the lender during the life of the agreement.
    • The report excludes unsecured personal loans that some consumers may use when buying a car, which the publisher believes is now a relatively minor form of car finance.
    • It includes agreements for vehicles that might be used for business purposes by individuals but are purchased by consumers rather than the businesses they run.

    The report:

    • Describes the overall used vehicle market size and historical growth rates.
    • Profiles 25 largest used vehicle loan providers.
    • Describes the role of brokers, including firms working with vehicle dealers and those dealing direct with consumers.
    • Reviews drivers of used vehicle loan growth, setting out historical trends and available forecasts.
    • Provides the forecast for the market to 2021, supported by evidence from market drivers and industry interviews.

    Key Topics Covered:

    About this report

    • What does the report contain?
    • What are the objectives of this report?
    • Who is it useful for?
    • What are the sources and methodology?

    Summary

    • The used car finance market

    Market size and growth

    • Outlook

    About the Publisher

    • Company background
    • Consulting services
    • Commercial/operational due diligence
    • Custom market analysis
    • Primary research
    • Growth strategy
    • Related research

    List of Charts and Tables

    • Used car finance market
    • Definition of the market
    • Types of finance offered to purchase cars
    • Hire Purchase
    • Personal Contract Plan (PCP)
    • Lease
    • Alternative products
    • Non-POS car loan
    • Personal loan
    • Mortgage further advance
    • Credit Card
    • Types of customers

    Market size and growth

    • UK car market
    • Dealer sales
    • Franchised dealers
    • Independent dealers
    • Other vehicle distributors
    • Motor finance penetration
    • Motor finance volumes
    • Non-prime lending

    Market Drivers

    • Regulatory landscape
    • FCA authorisation
    • Regulatory requirements
    • Recent regulatory developments
    • UK Economic performance
    • Consumer borrowing
    • Ability to service borrowing
    • Wages
    • Source: Bank of England Financial Stability Report November 2017
    • Other market drivers

    Competitive landscape

    • Overview
    • Success factors in dealer POS finance
    • Market size and share
    • Sub-Prime sector
    • Split by channel

    Major lenders

    • Barclays Partner Finance
    • Black Horse (Lloyds Banking Group)
    • Close Brothers Motor Finance
    • Hitachi Capital
    • MotoNovo
    • Santander UK plc

    Other lenders

    • 1st Stop Car Finance
    • Advantage Finance
    • Alphera
    • Billing Finance
    • Blue Motor
    • First Response
    • JBR Capital
    • Mallard Vehicle Finance
    • Marsh
    • Moneybarn
    • Moneyway
    • NIIB Group
    • Oodle Financial Services
    • Paragon
    • Private & Commercial
    • Raphaels Bank
    • Startline
    • The Car Finance Company
    • Other funders
    • Admiral Loans
    • Car Finance Limited
    • Ratesetter
    • Car dealer finance brokers
    • Auto Union Finance
    • Creditas
    • DSG Financial Services
    • Eurodrive
    • Evolution Funding
    • Jigsaw Finance
    • Mann Island Finance
    • Motion Finance
    • Whichdeal Limited

    For more information about this report visit https://www.researchandmarkets.com/r/pehqza

    Contacts

    ResearchAndMarkets.com

    Laura Wood, Senior Press Manager

    press@researchandmarkets.com

    For E.S.T Office Hours Call 1-917-300-0470

    For U.S./CAN Toll Free Call 1-800-526-8630

    For GMT Office Hours Call +353-1-416-8900

  • Gyroscope Therapeutics Announces Positive Interim Data from Phase I/II FOCUS Trial of Investigational Gene Therapy GT005

    Interim Data Showed GT005 Was Well Tolerated in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

    Majority of Patients Treated with GT005 Had Increases in Complement Factor I (CFI) Levels, with an Average Increase of 146% Compared to Baseline

    Interim Data Demonstrated Potential for Single Administration of GT005 to Down-Regulate Overactive Complement System, a Key Driver of AMD

    LONDON–(BUSINESS WIRE)–Gyroscope Therapeutics Limited, a clinical-stage gene therapy company focused on diseases of the eye, today announced positive interim safety, protein expression and biomarker data from the ongoing open-label Phase I/II FOCUS clinical trial of its investigational gene therapy, GT005, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Interim results showed GT005 was well tolerated and resulted in sustained increases in vitreous Complement Factor I (CFI) levels in the majority of patients, as well as decreases in the downstream complement proteins associated with over-activation of the complement system. These results were observed both in GA patients who had rare variants in their CFI gene as well as those who did not. The data were presented today at the Angiogenesis, Exudation, and Degeneration 2021 virtual meeting by Nadia Waheed, M.D., MPH, Chief Medical Officer, Gyroscope Therapeutics.

    “Our investigational gene therapy, GT005, is designed to restore balance to an overactive complement system and reduce inflammation by increasing production of the CFI protein. We are excited by these early results from the FOCUS trial that showed GT005 has been well tolerated to date, increased CFI levels in a durable manner and caused down-regulation of an overactive complement system,” said Dr. Waheed. “These results give us confidence that a one-time treatment with GT005 may have the potential to slow progression of geographic atrophy, and this is being evaluated in our ongoing Phase II clinical trials.”

    “There is strong evidence that an overactive complement system is a key driver of dry AMD,” said Arshad Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at the University of Nevada, Reno School of Medicine, and an investigator in the FOCUS trial. “The recently released data from the FOCUS trial suggest the potential of a one-time gene therapy with GT005 to regulate an overactive complement system. It is encouraging that GT005 generated sustained increases in CFI in a majority of the patients, even in some patients treated more than a year ago. We continue to look forward to learning more about GT005 as a potential treatment for GA in the ongoing Phase II clinical trial programme.”

    Interim Data from the Phase I/II FOCUS Trial

    FOCUS [NCT03846193] is an open-label Phase I/II clinical trial evaluating the safety and dose response of three doses of GT005 given as a single subretinal injection to patients with GA secondary to AMD. The trial is divided into several cohorts, including dose escalation (Cohorts 1, 2, 3, 5 and 6) and dose expansion (Cohorts 4 and 7).

    Interim results were reported today from patients in Cohorts 1 to 4. The three doses of GT005 evaluated were well tolerated and there were no signs of GT005-induced inflammation.

    • There were no dose-related trends in the frequency or type of adverse events and no GT005-related serious adverse events.
    • There was one possible GT005-related adverse event, which was a suspected choroidal neovascularization of moderate intensity at the patient’s six-month follow up. This was successfully treated with anti-vascular endothelial growth factor (VEGF) therapy.
    • There were 12 adverse events considered to be related to the surgical procedure; the majority of these were mild (mild n=9; moderate n=3).

    Interim results showed sustained increases in vitreous CFI levels in the majority of patients, as well as decreases in the vitreous levels of key proteins associated with complement over-activation (Ba and C3 breakdown proteins: C3b, iC3b and C3c).

    • Nine out of 10 patients treated with GT005 had increases in CFI levels, with an average increase of 146% compared to baseline (p=0.02).
    • Of the nine patients with increased CFI levels, eight showed sustained increases at week 24 and beyond, with one showing a sustained increase at 84 weeks. The most recent measurement for the ninth patient with increased CFI levels was week 12.
    • Increases in CFI levels were observed in patients with rare variants in the CFI gene as well as those who did not have rare variants.
    • There was an average decrease of 41% in levels of the Ba protein compared to baseline at weeks 24 to 56 (n=6; p=0.03), and an average decrease of 42% in the C3 breakdown proteins compared to baseline at weeks 24 to 56 (n=9; p=0.03). These decreases were observed in patients with and without CFI rare variants.
    • There was a significant correlation between increased CFI levels and decreases in Ba levels (p=0.03).

    Dr. Waheed’s presentation will be made available on Gyroscope’s website at https://www.gyroscopetx.com/publications/.

    About GT005

    GT005 is designed as an AAV2-based one-time investigational gene therapy for GA secondary to AMD that is 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 CFI protein. Complement overactivation has been strongly correlated with the development and progression of AMD. The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production could dampen the system’s overactivity and reduce inflammation, with the goal of preserving a person’s eyesight.

    As of December 2020, 22 patients had been dosed with GT005 in the FOCUS trial across Cohorts 1 to 5. Dosing in Cohorts 1, 2, 3 and 5 is complete. Patients continue to be enrolled in the dose expansion Cohort 4, which is planned to enrol up to 20 patients. GT005 is delivered to patients in Cohorts 1 to 4 using the standard transvitreal procedure and in Cohorts 5 to 7 using Gyroscope’s proprietary Orbit™ subretinal delivery system.

    Gyroscope is also evaluating GT005 in two Phase II clinical trials. EXPLORE [NCT04437368] and HORIZON [NCT04566445] are Phase II, multicentre, randomised, controlled trials evaluating the safety and effectiveness of GT005 administered as a single subretinal injection. The primary endpoint for both trials is progression of GA over 48 weeks. EXPLORE is enrolling people who have GA secondary to AMD who have rare variants in their CFI gene. 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 50 and is a devastating diagnosis.1 There are currently no approved treatments for dry AMD, which is the most common form, 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 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.

    Syncona Ltd., our lead investor, helped us create a leading gene therapy company 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: www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.

    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 August 17, 2020. Accessed July 16, 2020.

    2 American Macular Degeneration Foundation. What is Macular Degeneration? https://www.macular.org/what-macular-degeneration. Page last reviewed December 20, 2017. Accessed February 11, 2021.

    Contacts

    Charlotte Arnold

    VP, Corporate Affairs

    Gyroscope Therapeutics

    media@gyroscopetx.com

  • Gyroscope Therapeutics Announces Positive Interim Data from Phase I/II FOCUS Trial of Investigational Gene Therapy GT005

    Interim Data Showed GT005 Was Well Tolerated in Patients with Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)

    Majority of Patients Treated with GT005 Had Increases in Complement Factor I (CFI) Levels, with an Average Increase of 146% Compared to Baseline

    Interim Data Demonstrated Potential for Single Administration of GT005 to Down-Regulate Overactive Complement System, a Key Driver of AMD

    LONDON–(BUSINESS WIRE)–Gyroscope Therapeutics Limited, a clinical-stage gene therapy company focused on diseases of the eye, today announced positive interim safety, protein expression and biomarker data from the ongoing open-label Phase I/II FOCUS clinical trial of its investigational gene therapy, GT005, in patients with geographic atrophy (GA) secondary to age-related macular degeneration (AMD). Interim results showed GT005 was well tolerated and resulted in sustained increases in vitreous Complement Factor I (CFI) levels in the majority of patients, as well as decreases in the downstream complement proteins associated with over-activation of the complement system. These results were observed both in GA patients who had rare variants in their CFI gene as well as those who did not. The data were presented today at the Angiogenesis, Exudation, and Degeneration 2021 virtual meeting by Nadia Waheed, M.D., MPH, Chief Medical Officer, Gyroscope Therapeutics.

    “Our investigational gene therapy, GT005, is designed to restore balance to an overactive complement system and reduce inflammation by increasing production of the CFI protein. We are excited by these early results from the FOCUS trial that showed GT005 has been well tolerated to date, increased CFI levels in a durable manner and caused down-regulation of an overactive complement system,” said Dr. Waheed. “These results give us confidence that a one-time treatment with GT005 may have the potential to slow progression of geographic atrophy, and this is being evaluated in our ongoing Phase II clinical trials.”

    “There is strong evidence that an overactive complement system is a key driver of dry AMD,” said Arshad Khanani, M.D., M.A., Director of Clinical Research at Sierra Eye Associates, Clinical Associate Professor at the University of Nevada, Reno School of Medicine, and an investigator in the FOCUS trial. “The recently released data from the FOCUS trial suggest the potential of a one-time gene therapy with GT005 to regulate an overactive complement system. It is encouraging that GT005 generated sustained increases in CFI in a majority of the patients, even in some patients treated more than a year ago. We continue to look forward to learning more about GT005 as a potential treatment for GA in the ongoing Phase II clinical trial programme.”

    Interim Data from the Phase I/II FOCUS Trial

    FOCUS [NCT03846193] is an open-label Phase I/II clinical trial evaluating the safety and dose response of three doses of GT005 given as a single subretinal injection to patients with GA secondary to AMD. The trial is divided into several cohorts, including dose escalation (Cohorts 1, 2, 3, 5 and 6) and dose expansion (Cohorts 4 and 7).

    Interim results were reported today from patients in Cohorts 1 to 4. The three doses of GT005 evaluated were well tolerated and there were no signs of GT005-induced inflammation.

    • There were no dose-related trends in the frequency or type of adverse events and no GT005-related serious adverse events.
    • There was one possible GT005-related adverse event, which was a suspected choroidal neovascularization of moderate intensity at the patient’s six-month follow up. This was successfully treated with anti-vascular endothelial growth factor (VEGF) therapy.
    • There were 12 adverse events considered to be related to the surgical procedure; the majority of these were mild (mild n=9; moderate n=3).

    Interim results showed sustained increases in vitreous CFI levels in the majority of patients, as well as decreases in the vitreous levels of key proteins associated with complement over-activation (Ba and C3 breakdown proteins: C3b, iC3b and C3c).

    • Nine out of 10 patients treated with GT005 had increases in CFI levels, with an average increase of 146% compared to baseline (p=0.02).
    • Of the nine patients with increased CFI levels, eight showed sustained increases at week 24 and beyond, with one showing a sustained increase at 84 weeks. The most recent measurement for the ninth patient with increased CFI levels was week 12.
    • Increases in CFI levels were observed in patients with rare variants in the CFI gene as well as those who did not have rare variants.
    • There was an average decrease of 41% in levels of the Ba protein compared to baseline at weeks 24 to 56 (n=6; p=0.03), and an average decrease of 42% in the C3 breakdown proteins compared to baseline at weeks 24 to 56 (n=9; p=0.03). These decreases were observed in patients with and without CFI rare variants.
    • There was a significant correlation between increased CFI levels and decreases in Ba levels (p=0.03).

    Dr. Waheed’s presentation will be made available on Gyroscope’s website at https://www.gyroscopetx.com/publications/.

    About GT005

    GT005 is designed as an AAV2-based one-time investigational gene therapy for GA secondary to AMD that is 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 CFI protein. Complement overactivation has been strongly correlated with the development and progression of AMD. The CFI protein regulates the activity of the complement system. It is believed that increasing CFI production could dampen the system’s overactivity and reduce inflammation, with the goal of preserving a person’s eyesight.

    As of December 2020, 22 patients had been dosed with GT005 in the FOCUS trial across Cohorts 1 to 5. Dosing in Cohorts 1, 2, 3 and 5 is complete. Patients continue to be enrolled in the dose expansion Cohort 4, which is planned to enrol up to 20 patients. GT005 is delivered to patients in Cohorts 1 to 4 using the standard transvitreal procedure and in Cohorts 5 to 7 using Gyroscope’s proprietary Orbit™ subretinal delivery system.

    Gyroscope is also evaluating GT005 in two Phase II clinical trials. EXPLORE [NCT04437368] and HORIZON [NCT04566445] are Phase II, multicentre, randomised, controlled trials evaluating the safety and effectiveness of GT005 administered as a single subretinal injection. The primary endpoint for both trials is progression of GA over 48 weeks. EXPLORE is enrolling people who have GA secondary to AMD who have rare variants in their CFI gene. 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 50 and is a devastating diagnosis.1 There are currently no approved treatments for dry AMD, which is the most common form, 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 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.

    Syncona Ltd., our lead investor, helped us create a leading gene therapy company 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: www.gyroscopetx.com and follow us on Twitter (@GyroscopeTx) and on LinkedIn.

    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 August 17, 2020. Accessed July 16, 2020.

    2 American Macular Degeneration Foundation. What is Macular Degeneration? https://www.macular.org/what-macular-degeneration. Page last reviewed December 20, 2017. Accessed February 11, 2021.

    Contacts

    Charlotte Arnold

    VP, Corporate Affairs

    Gyroscope Therapeutics

    media@gyroscopetx.com

  • Next-generation Data Management Platform Solidatus Raises £14 Million in Series A Funding
    • Solidatus rapidly delivers a trusted 360 view of an organisation’s data flows, enabling insightful, sustainable and impactful data management
    • Solidatus has raised £14m in Series A funding following a successful year which saw it double in size, quadruple in revenue, and boost expansion into the US and Asia
    • B2B enterprise fund AlbionVC led the round, which also includes two of Solidatus’ global enterprise clients, HSBC and Citi

    LONDON–(BUSINESS WIRE)–Solidatus, the award-winning data lineage and metadata management company, today announces it has raised £14m ($19.2m+) in Series A funding to transform how organisations view, understand and manage data. AlbionVC led the round, which also includes HSBC Ventures, and Citi, two of Solidatus’ global enterprise clients. The deal was led by Emil Gigov and Jay Wilson of AlbionVC with Jay Wilson joining the Solidatus’ Board of Directors following the investment.


    Solidatus empowers organisations to effectively map, manage and monetise their key asset – data. Businesses across the world are dealing with complex data points and the lineage-first approach championed by Solidatus offers up to 90% efficiency savings over traditional methods. Clients, including top-tier global financial, pharmaceutical and consulting firms, are using the software to visualise and understand their data estate, taking advantage of the ability to track data through their enterprise to drive business intelligence, digital transformation and regulatory compliance.

    Last year marked the company’s most successful year to date, seeing Solidatus more than double in size, quadruple its revenue whilst maintaining profitability. The business became the only new entrant to the Gartner Magic Quadrant in Metadata Management, one of the youngest companies to place in the Quadrant’s history. Solidatus expanded into several new sectors, including aerospace, manufacturing, telecommunications and government, and has four of the top 10 Globally Systemically Important Banks (GSIBs) in the European and US markets as clients. Solidatus was also awarded Best Data Governance Solution by Data Management Insights.

    The Series A investment sees growth partner, AlbionVC, and strategic partner, HSBC, join Citi to support Solidatus’ vision to revolutionise data engineering. The aim is to fast-track its planned global expansion, further extending into new territories including the US, Europe and Asia, as well as delivering best-in-class data management capabilities to new industry verticals.

    Kate Platonova, Chief Data and Architecture Officer, HSBC said: “As a large global bank, we manage complex organisational metadata. Through our partnership with Solidatus we have dramatically improved some of our workflows, reducing both the risk and speed to market for some of our major international programmes. Their graph technology has been particularly instrumental in helping us to achieve this. As management of metadata becomes ever more critical to success, we believe Solidatus will play an increasingly strategic role for HSBC in the future.”

    Philip Dutton, co-founder of Solidatus said: “Solidatus was built to revolutionise the data economy. The completion of Series A is confirmation that we’ve engineered the right solution to meet the complex needs of data-rich and regulated organisations, delivering a modern, agile and scalable solution. We are looking forward to working alongside our investors to accelerate the delivery of organisational transformation and control to new markets and clients with the same level of commitment to the highest standards of service that are key to the Solidatus offering.”

    Jay Wilson, investor at AlbionVC and Solidatus board member said: “The increasing complexity of an organisation’s data estates and the growing recognition of data as an asset combined with increasing regulatory demands is bringing data management into the limelight. Solidatus has built the best-in-class product to bear down on the industry’s pain points and we are delighted to lead the company’s first institutional capital raise to support the co-founders and the company in reshaping data lineage and the wider data management category.”

    The investment round comes shortly ahead of Solidatus’ participation in the UK Department of International Trade’s Virtual US RegTech Roadshow, taking place at the end of February 2021. The roadshow connects a select group of leading UK RegTechs with key USA financial services stakeholders.

    Alastair Lukies, CBE, Member of the Prime Minister’s Business Council and Chair of the Fintech Alliance, comments: “The UK’s tech sector is a great global success story, for FinTech and RegTech in particular. This US Roadshow will further reinforce the UK’s world-leading innovation in this space. I’ve known Solidatus as a business for some time and achieving this milestone in their growth, especially from such renowned investors and at such a significant level, is testament to both the business’ proposition, innovation and service to their customers. It signals a fantastic start to 2021 for British tech businesses and underlines how the country’s tech sector is making waves on a truly global scale.”

    Contacts

    Media enquiries:

    Kat Jackson, Franklin Rae PR

    solidatus@franklinrae.com
    020 3011 1023

    press@solidatus.com

  • Next-generation Data Management Platform Solidatus Raises £14 Million in Series A Funding
    • Solidatus rapidly delivers a trusted 360 view of an organisation’s data flows, enabling insightful, sustainable and impactful data management
    • Solidatus has raised £14m in Series A funding following a successful year which saw it double in size, quadruple in revenue, and boost expansion into the US and Asia
    • B2B enterprise fund AlbionVC led the round, which also includes two of Solidatus’ global enterprise clients, HSBC and Citi

    LONDON–(BUSINESS WIRE)–Solidatus, the award-winning data lineage and metadata management company, today announces it has raised £14m ($19.2m+) in Series A funding to transform how organisations view, understand and manage data. AlbionVC led the round, which also includes HSBC Ventures, and Citi, two of Solidatus’ global enterprise clients. The deal was led by Emil Gigov and Jay Wilson of AlbionVC with Jay Wilson joining the Solidatus’ Board of Directors following the investment.


    Solidatus empowers organisations to effectively map, manage and monetise their key asset – data. Businesses across the world are dealing with complex data points and the lineage-first approach championed by Solidatus offers up to 90% efficiency savings over traditional methods. Clients, including top-tier global financial, pharmaceutical and consulting firms, are using the software to visualise and understand their data estate, taking advantage of the ability to track data through their enterprise to drive business intelligence, digital transformation and regulatory compliance.

    Last year marked the company’s most successful year to date, seeing Solidatus more than double in size, quadruple its revenue whilst maintaining profitability. The business became the only new entrant to the Gartner Magic Quadrant in Metadata Management, one of the youngest companies to place in the Quadrant’s history. Solidatus expanded into several new sectors, including aerospace, manufacturing, telecommunications and government, and has four of the top 10 Globally Systemically Important Banks (GSIBs) in the European and US markets as clients. Solidatus was also awarded Best Data Governance Solution by Data Management Insights.

    The Series A investment sees growth partner, AlbionVC, and strategic partner, HSBC, join Citi to support Solidatus’ vision to revolutionise data engineering. The aim is to fast-track its planned global expansion, further extending into new territories including the US, Europe and Asia, as well as delivering best-in-class data management capabilities to new industry verticals.

    Kate Platonova, Chief Data and Architecture Officer, HSBC said: “As a large global bank, we manage complex organisational metadata. Through our partnership with Solidatus we have dramatically improved some of our workflows, reducing both the risk and speed to market for some of our major international programmes. Their graph technology has been particularly instrumental in helping us to achieve this. As management of metadata becomes ever more critical to success, we believe Solidatus will play an increasingly strategic role for HSBC in the future.”

    Philip Dutton, co-founder of Solidatus said: “Solidatus was built to revolutionise the data economy. The completion of Series A is confirmation that we’ve engineered the right solution to meet the complex needs of data-rich and regulated organisations, delivering a modern, agile and scalable solution. We are looking forward to working alongside our investors to accelerate the delivery of organisational transformation and control to new markets and clients with the same level of commitment to the highest standards of service that are key to the Solidatus offering.”

    Jay Wilson, investor at AlbionVC and Solidatus board member said: “The increasing complexity of an organisation’s data estates and the growing recognition of data as an asset combined with increasing regulatory demands is bringing data management into the limelight. Solidatus has built the best-in-class product to bear down on the industry’s pain points and we are delighted to lead the company’s first institutional capital raise to support the co-founders and the company in reshaping data lineage and the wider data management category.”

    The investment round comes shortly ahead of Solidatus’ participation in the UK Department of International Trade’s Virtual US RegTech Roadshow, taking place at the end of February 2021. The roadshow connects a select group of leading UK RegTechs with key USA financial services stakeholders.

    Alastair Lukies, CBE, Member of the Prime Minister’s Business Council and Chair of the Fintech Alliance, comments: “The UK’s tech sector is a great global success story, for FinTech and RegTech in particular. This US Roadshow will further reinforce the UK’s world-leading innovation in this space. I’ve known Solidatus as a business for some time and achieving this milestone in their growth, especially from such renowned investors and at such a significant level, is testament to both the business’ proposition, innovation and service to their customers. It signals a fantastic start to 2021 for British tech businesses and underlines how the country’s tech sector is making waves on a truly global scale.”

    Contacts

    Media enquiries:

    Kat Jackson, Franklin Rae PR

    solidatus@franklinrae.com
    020 3011 1023

    press@solidatus.com