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Press release

Trading and Business Update

May 14, 2020

Sensyne Health plc (LSE: SENS), the UK Clinical AI technology company, today announces a trading update (unaudited) for the year ended 30 April 2020. The Company will report its audited full year 2020 results in September 2020.

Highlights:

  • Strong revenue growth
  • Increasing demand for Sensyne remote monitoring products
  • GDm-Health, CVm-Health and BPm-Health products supplied free to NHS duringCOVID-19 pandemic
  • New commercial research agreement signed with Alexion
  • Appointment of Professor Sir Bruce Keogh KBE as permanent Chairman of the board of directors

Oxford, U.K. 14 May 2020:

The Company expects to report full year revenues of £2.1 million (FY19: £0.136 million), slightly ahead of guidance provided in January 2020 and largely driven by momentum in H2 2020.

Cash and cash equivalents were approximately £31.6 million (FY19: £49.3 million) reflecting continued investment in R&D.

COVID-19 has rapidly accelerated the adoption of digital technologies in healthcare systems around the world. Advancing patient care and accelerating the development of new medicines through the fusion of software, data science and machine learning technology with medical science are the very foundations of Sensyne Health.

The Company has a proven track record and embedded expert resource in these areas, particularly in remote patient monitoring and clinical AI. Consequently, Sensyne is seeing increasing demand for its products and technology as individuals, healthcare systems and the biopharmaceutical industry adapt to the current situation and make plans for a rapidly digitising healthcare future.

As such, The Company anticipates performing in line with the Board's expectations for the full year 2021 and the Board looks forward to the future of the Group with great confidence.

 

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:  

“Sensyne has adapted well to the changing environment brought on by COVID-19, is performing strongly and, whilst remaining prudent in light of the coronavirus pandemic, is well placed to deliver strong revenue growth during 2020/21.”  

Operational performance

 

COVID-19 and working with the NHS

The Company has continued to monitor and respond to the rapidly changing global situation, including guidance and policy changes implemented by governments around the world. Sensyne’s priority has been and continues to be on the health and wellbeing of its staff. The COVID-19 pandemic has had a major impact on NHS pressures, priorities and the allocation of NHS resources. Sensyne has not been directly affected negatively by the pandemic and has responded well by shifting the focus of its work in collaboration with its partner NHS Trusts in line with these changes, both in terms of supporting the shift to remote patient monitoring and in the use of Clinical AI. The Company has not furloughed any staff, nor has it participated in any of the other COVID-19 related government assistance schemes.

 

Sensyne responds with remote monitoring products during COVID-19

The Company has seen an acceleration in the adoption of tools by the NHS that enable remote monitoring of patients and this has led to increased demand and interest in the Company’s new and existing remote monitoring products including GDm-Health (diabetes in pregnancy monitoring), CVm-Health (remote COVID-19 symptom monitoring) and BPm-Health (blood pressure monitoring in pregnancy).   

The anonymised data sets generated by these products have in turn increased significantly. Sensyne expects that the recent growth in remote patient monitoring will be maintained post the pandemic and the Company is well placed to grow its business in this area in the future.

 

Progress with NHS agreements and achievement of research objectives

UK Government policy towards the use of patient data and the development of tools has changed significantly in recent months following the creation of NHSX and this change has accelerated in response to the pandemic, with NHSX focused on the development of the track & trace app and the creation of a central national database. The UK is increasingly centralising data assets under the control of NHSX and NHS Digital and, in addition to the pressures caused by the coronavirus pandemic, this is slowing the ability of NHS Trusts to enter into individual agreements with Sensyne. The Company is awaiting approval for agreements that it entered into in 2019 with Wye Valley and George Eliot NHS Trusts. The Company is currently in discussions with a number of additional NHS Trusts and discussions are taking longer than the Company has experienced previously. The projects with our existing partners Oxford University Hospitals, Chelsea & Westminster and South Warwickshire NHS Foundation Trusts are progressing well and the Company has been able to achieve its research objectives for its partners and customers.

 

Business re-organisation well positioned for growth

In Autumn 2019 Sensyne re-organised its business into two operating divisions, Discovery Sciences (DS) and Software Products (SP), to improve customer focus. The DS division focuses on providing services and products to pharmaceutical clients and the SP division focuses on providing services and products to healthcare providers such as the NHS. This re-organisation has been successfully implemented, led by the Company’s strengthened management team, and has led to an enhanced performance in H2 2020, providing Sensyne with a strong platform for growth, both organically and by potential acquisitions.

 

Discovery Sciences

Over the year, the DS division has grown to a team of more than 35 scientists with backgrounds in machine learning, bioinformatics and epidemiology, working closely with clinicians and biologists, to build a highly skilled interdisciplinary team.

In response to COVID-19, working in close co-operation with clinicians at Chelsea & Westminster NHS Foundation Trust, the DS team has developed algorithms using computer vision for the analysis of images to automatically detect COVID-19 in the lungs and algorithms to identify patients at risk of poor outcomes fromCOVID-19 infection based on analysis of EPR data.

 

Commercial research contract with Alexion

Sensyne has entered into a collaboration with Alexion, aNASDAQ listed global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. The collaboration will focus on studying the prevalence and outcomes of patients in disease areas of interest to Alexion Financial terms have not been disclosed.

 

Pharmapartnerships

With the recent addition of Alexion, the Company is working with 3 pharmaceutical companies, including Bayer and Roche. The work under these commercial research contracts has continued to progress well including during the coronavirus lockdown, but, as is common with these agreements, the Company is extremely limited in what it can report in terms of progress.  

Not withstanding the uncertainties caused by the COVID-19 pandemic, the Company’s business development activities continue.  Further updates will be provided as and when appropriate.  

 

 

Software Products

 

CVm-Health

CVm-Health, which is currently tailored towards COVID-19 response, is an app that was on the Company’s development roadmap for the future. Working effectively with Microsoft and Cognizant, the Company was able to develop and launch CVm-Health rapidly.  The CVm-Health ‘Good Neighbour’ app, was developed to provide a secure way for individuals to monitor and report the management of their health for COVID-19 related symptoms.  The strategy for  CVm-Health is to grow the platform both in the UK and internationally over time to be an effective system for remote monitoring of individuals of high risk to COVID-19.

CVm-Health was originally developed as a partnership product, but Sensyne launched CVm-Health as a free public service during the pandemic.  Since launch, functionality has been enhanced  through the addition of respiratory rate monitoring and the Health Diary, which enables users to see all recorded data for themselves and the people they monitor; soon users will be able to share this health diary with others, for example their healthcare provider.  In addition, given the vulnerability of the Black, Asian and minority ethnic community to COVID-19, the ability to add ethnicity data has been added. The next milestone will be the launch in theUSA. Technical development of the US version of CVm-Health will be completed later in May.  The ongoing aim forCVm-Health is to monitor specific population groups, in partnership with other organisations, and the Company continues to talk to organisations in the fields of health, social care and supported living. Recently, the Company has started to engage with employers and educational institutions who are looking for tools to support their management of employees and students who are returning after the coronavirus lockdown.

 

GDm-Health

The GDm-Health prescribed digital therapeutic product for the remote management of diabetes in pregnancy has been adopted by 10 new NHS Trusts going live in the past month bringing the total number of Trusts using GDm-Health to 23. A further 8 Trusts are awaiting ‘go-live’ and an additional 28 Trusts are in discussions to implement the system in their hospitals. The work with Jefferson Health for the clinical and economic evaluation of GDm-Health within a US hospital system is progressing well. The first clinical use of the product commenced in March 2020 and the product is on track for US launch, as planned, later in the financial year.

The benefit to patients and real-world impact in using GDm-Health continues to grow.  As at the year end, an extrapolation of results from the randomized controlled trial suggest use of GDm-Health should have prevented a total of 2,096 c-sections, 1,246 mothers not needing to transition to pharmacological treatments and saved 16,545 clinic visits. This represent a 60% increase in the number of women using GDm-Health since the full year results published in October 2018.    

 

SYNE

With the collaboration of our clinical partners, Sensyne has continued to develop the SYNE™ GDM/001 algorithm to identify mothers at risk of transitioning to medication therapy. With the guidance of our regulatory and quality team we are ready to deploy SYNE GDM/001 within GDm-Health at two NHS Trusts in early summer to complete our clinical deployment of this algorithm.

 

BPm-Health

The SP division has further strengthened its market position in the remote management of women patients during pregnancy with the development of BPm-Health, a prescribed digital therapeutic product for the remote monitoring of blood pressure during pregnancy, which was launched on 5 May 2020. The Company sees an interesting opportunity to build its franchise for remote monitoring applications in women’s health and is exploring further opportunities in this area.

 

Update on SP collaborations

The collaborations with Cognizant andMicrosoft that were established in late 2019 are delivering results as demonstrated by the rapid deployment of CVm-Health, accelerating the rate of development and deployment of software applications developed by the SP division and Sensyne expects these to underpin further progress and the entry of the Company’s products in the US market in the current financial year.

 

Sensyne’s high quality and robust regulatory framework

Sensyne has continued to invest in its quality and regulatory system framework for digital health applications andClinical AI to facilitate the development and launch of its clinically validated products and services in its two lead markets; the UK and US. This included a number of notable achievements that underpin the strength of the Company’s Quality Management System and information governance and compliance to Medical Device Directive, Medical Device Regulation and 21.CFR.820(US-FDA).  These include:

  • accreditation to ISO13485 (independently audited by BSI)
  • accreditation to ISO27001 (independently audited by BSI)
  • compliance to DSP Toolkit (NHS requirement for Information Governance compliance)
  • compliance to DCB0129 (NHS requirement for clinical risk management)
  • compliance to IG framework respecting GDPR requirements, Caldicott Principles and UK GovernmentCode of Conduct for Digital Health Technology
  • MHRA registration of GDm-Health, SEND and BPm-Health products
  • successful QMS transition to Medical Device Regulation (from Medical Device Directive) 1 year in advance of required transition deadline (May 2021)
  • undertook research with MHRA for a special project on “the creation of synthetic dataset for validation of AI algorithms”
  • listing in the NICE case studies for digital technologies
  • inclusion in the CQC regulatory sandbox for digital technologies

 

LAB10x partnership

The LAB10x partnership established during the year with Evotec, Oxford University Innovation, Oxford Sciences Innovation and the University of Oxford is working well with the first project now launched; ParkAI, a new software application for the management of Parkinson’s disease led by Prof Michelle Hu in the Nuffield Department of ClinicalNeurosciences, University of Oxford.

 

Strengthened management team

Over the period, Sensyne has strengthened its senior management team and grown total headcount in a very competitive market for talent.  105 people are employed by the Company as at 30 April 2020 (of which 57 have PhDs or similar postgraduate qualification).  Key appointments include:

  • Alan Payne as Chief Information Officer.  Alan has led global technology divisions for over 20 years for many multi-nationals including Aetna International, NuffieldHealth, JPMorganChase, Merrill Lynch, Oracle and AIG, and is an Honorary Professor in Intelligent Systems at UCL
  • Dr Lucy Mackillop as Chief Medical Officer, having been an advisor to the Company since October 2018. Lucy is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford
  • James Chandler as VP Communications, joining from BenevolentAI where he held the same role leading all marketing and communications
  • Laura Hillier, currently Legal Director (UK & Ireland) Pharmaceuticals GSK, will join Sensyne as General Counsel and Company Secretary on 1 August 2020. She has previously been Assistant General Counsel at ViiV Healthcare and a solicitor with Slaughter and May.
  • Sensyne has initiated the search for a new, permanent CFO with deep experience of public markets and corporate transactions in the UK and USA to reflect the Company’s future ambitions.

 

Corporate Governance

Following consultation with shareholders following the AGM in 2019 the Board has been progressing a number of matters to strengthen the Company’s corporate governance.

 

Chairman appointment

The Company is delighted to announce that Professor Sir Bruce Keogh KBE has agreed to become the permanent Chairman of the board of directors, having served as an independent director since 10 August 2018 and as interim Chairman since 10 December 2019. One of the UK’s leading doctors, Sir Bruce is Chairman of Birmingham Women’s and Children’s NHS Foundation Trust, having served as NHS England’s National Medical Director for 10 years where he was responsible for clinical leadership, quality and innovation. Before this he enjoyed a distinguished career in surgery, working as a consultant cardiac surgeon at University Hospitals Birmingham before becoming Director of Surgery at the Heart Hospital and Professor of CardiacSurgery at University College London.

Sir Bruce’s appointment to Chairman follows an external process to identify Chair candidates. Whilst a number of strong external candidates were considered, the Board concluded that Sir Bruce leading a Board further strengthened by additional independent non-executive directors was in the best interests of the Company.

 

Non-executive Directors

The Nomination Committee is actively seeking a Senior Independent Director, and two additional non-executive Directors to strengthen board committees. With the Chairman’s appointment now confirmed, the appointment of these additional non-executive Directors can now be completed, and further announcements on Board composition will be made in due course.

 

Remuneration policy for 2019/20 and2020/21

The Remuneration Committee undertook an extensive review of remuneration for the Company’s senior management team advised by Aon Consultants. The Remuneration Committee consulted with shareholders on the outcome of this review and revised Remuneration policies for 2019/20 and for 2020/21 were adopted by the Board following investor feedback. During this review period, Lord Drayson has received a salary of £1 per annum since 22 October 2019.  In line with the Company’s revised Remuneration policy, the basic salary for the CEO, Lord Drayson, for all of 2019/20 and for 2020/21 was set at £500,000 per annum. Not withstanding objective operational progress made throughout 2019/20, the Board and Lord Drayson have agreed that Lord Drayson will waive receipt of and not receive his performance related bonus for the full year 2019/20 in light of the COVID-19 pandemic and in recognition of the Company’s depressed share price.

 

Corporate Governance review

A&O Consultants were appointed to conduct an independent review of corporate governance and this work was completed and reported to the Board in January2020. The Company seeks to apply The UK Corporate Governance Code, the highest standard which is mandatory for listed companies and optional for AIM-quoted companies such as Sensyne. No significant breaches of, or gaps in, corporate governance were identified by the review although a number of areas for improvement of internal processes and communications were recommended. The Company is currently implementing these improvements.

Press release

Trading and Business Update

May 14, 2020

Sensyne Health plc (LSE: SENS), the UK Clinical AI technology company, today announces a trading update (unaudited) for the year ended 30 April 2020. The Company will report its audited full year 2020 results in September 2020.

Highlights:

  • Strong revenue growth
  • Increasing demand for Sensyne remote monitoring products
  • GDm-Health, CVm-Health and BPm-Health products supplied free to NHS duringCOVID-19 pandemic
  • New commercial research agreement signed with Alexion
  • Appointment of Professor Sir Bruce Keogh KBE as permanent Chairman of the board of directors

Oxford, U.K. 14 May 2020:

The Company expects to report full year revenues of £2.1 million (FY19: £0.136 million), slightly ahead of guidance provided in January 2020 and largely driven by momentum in H2 2020.

Cash and cash equivalents were approximately £31.6 million (FY19: £49.3 million) reflecting continued investment in R&D.

COVID-19 has rapidly accelerated the adoption of digital technologies in healthcare systems around the world. Advancing patient care and accelerating the development of new medicines through the fusion of software, data science and machine learning technology with medical science are the very foundations of Sensyne Health.

The Company has a proven track record and embedded expert resource in these areas, particularly in remote patient monitoring and clinical AI. Consequently, Sensyne is seeing increasing demand for its products and technology as individuals, healthcare systems and the biopharmaceutical industry adapt to the current situation and make plans for a rapidly digitising healthcare future.

As such, The Company anticipates performing in line with the Board's expectations for the full year 2021 and the Board looks forward to the future of the Group with great confidence.

 

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:  

“Sensyne has adapted well to the changing environment brought on by COVID-19, is performing strongly and, whilst remaining prudent in light of the coronavirus pandemic, is well placed to deliver strong revenue growth during 2020/21.”  

Operational performance

 

COVID-19 and working with the NHS

The Company has continued to monitor and respond to the rapidly changing global situation, including guidance and policy changes implemented by governments around the world. Sensyne’s priority has been and continues to be on the health and wellbeing of its staff. The COVID-19 pandemic has had a major impact on NHS pressures, priorities and the allocation of NHS resources. Sensyne has not been directly affected negatively by the pandemic and has responded well by shifting the focus of its work in collaboration with its partner NHS Trusts in line with these changes, both in terms of supporting the shift to remote patient monitoring and in the use of Clinical AI. The Company has not furloughed any staff, nor has it participated in any of the other COVID-19 related government assistance schemes.

 

Sensyne responds with remote monitoring products during COVID-19

The Company has seen an acceleration in the adoption of tools by the NHS that enable remote monitoring of patients and this has led to increased demand and interest in the Company’s new and existing remote monitoring products including GDm-Health (diabetes in pregnancy monitoring), CVm-Health (remote COVID-19 symptom monitoring) and BPm-Health (blood pressure monitoring in pregnancy).   

The anonymised data sets generated by these products have in turn increased significantly. Sensyne expects that the recent growth in remote patient monitoring will be maintained post the pandemic and the Company is well placed to grow its business in this area in the future.

 

Progress with NHS agreements and achievement of research objectives

UK Government policy towards the use of patient data and the development of tools has changed significantly in recent months following the creation of NHSX and this change has accelerated in response to the pandemic, with NHSX focused on the development of the track & trace app and the creation of a central national database. The UK is increasingly centralising data assets under the control of NHSX and NHS Digital and, in addition to the pressures caused by the coronavirus pandemic, this is slowing the ability of NHS Trusts to enter into individual agreements with Sensyne. The Company is awaiting approval for agreements that it entered into in 2019 with Wye Valley and George Eliot NHS Trusts. The Company is currently in discussions with a number of additional NHS Trusts and discussions are taking longer than the Company has experienced previously. The projects with our existing partners Oxford University Hospitals, Chelsea & Westminster and South Warwickshire NHS Foundation Trusts are progressing well and the Company has been able to achieve its research objectives for its partners and customers.

 

Business re-organisation well positioned for growth

In Autumn 2019 Sensyne re-organised its business into two operating divisions, Discovery Sciences (DS) and Software Products (SP), to improve customer focus. The DS division focuses on providing services and products to pharmaceutical clients and the SP division focuses on providing services and products to healthcare providers such as the NHS. This re-organisation has been successfully implemented, led by the Company’s strengthened management team, and has led to an enhanced performance in H2 2020, providing Sensyne with a strong platform for growth, both organically and by potential acquisitions.

 

Discovery Sciences

Over the year, the DS division has grown to a team of more than 35 scientists with backgrounds in machine learning, bioinformatics and epidemiology, working closely with clinicians and biologists, to build a highly skilled interdisciplinary team.

In response to COVID-19, working in close co-operation with clinicians at Chelsea & Westminster NHS Foundation Trust, the DS team has developed algorithms using computer vision for the analysis of images to automatically detect COVID-19 in the lungs and algorithms to identify patients at risk of poor outcomes fromCOVID-19 infection based on analysis of EPR data.

 

Commercial research contract with Alexion

Sensyne has entered into a collaboration with Alexion, aNASDAQ listed global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. The collaboration will focus on studying the prevalence and outcomes of patients in disease areas of interest to Alexion Financial terms have not been disclosed.

 

Pharmapartnerships

With the recent addition of Alexion, the Company is working with 3 pharmaceutical companies, including Bayer and Roche. The work under these commercial research contracts has continued to progress well including during the coronavirus lockdown, but, as is common with these agreements, the Company is extremely limited in what it can report in terms of progress.  

Not withstanding the uncertainties caused by the COVID-19 pandemic, the Company’s business development activities continue.  Further updates will be provided as and when appropriate.  

 

 

Software Products

 

CVm-Health

CVm-Health, which is currently tailored towards COVID-19 response, is an app that was on the Company’s development roadmap for the future. Working effectively with Microsoft and Cognizant, the Company was able to develop and launch CVm-Health rapidly.  The CVm-Health ‘Good Neighbour’ app, was developed to provide a secure way for individuals to monitor and report the management of their health for COVID-19 related symptoms.  The strategy for  CVm-Health is to grow the platform both in the UK and internationally over time to be an effective system for remote monitoring of individuals of high risk to COVID-19.

CVm-Health was originally developed as a partnership product, but Sensyne launched CVm-Health as a free public service during the pandemic.  Since launch, functionality has been enhanced  through the addition of respiratory rate monitoring and the Health Diary, which enables users to see all recorded data for themselves and the people they monitor; soon users will be able to share this health diary with others, for example their healthcare provider.  In addition, given the vulnerability of the Black, Asian and minority ethnic community to COVID-19, the ability to add ethnicity data has been added. The next milestone will be the launch in theUSA. Technical development of the US version of CVm-Health will be completed later in May.  The ongoing aim forCVm-Health is to monitor specific population groups, in partnership with other organisations, and the Company continues to talk to organisations in the fields of health, social care and supported living. Recently, the Company has started to engage with employers and educational institutions who are looking for tools to support their management of employees and students who are returning after the coronavirus lockdown.

 

GDm-Health

The GDm-Health prescribed digital therapeutic product for the remote management of diabetes in pregnancy has been adopted by 10 new NHS Trusts going live in the past month bringing the total number of Trusts using GDm-Health to 23. A further 8 Trusts are awaiting ‘go-live’ and an additional 28 Trusts are in discussions to implement the system in their hospitals. The work with Jefferson Health for the clinical and economic evaluation of GDm-Health within a US hospital system is progressing well. The first clinical use of the product commenced in March 2020 and the product is on track for US launch, as planned, later in the financial year.

The benefit to patients and real-world impact in using GDm-Health continues to grow.  As at the year end, an extrapolation of results from the randomized controlled trial suggest use of GDm-Health should have prevented a total of 2,096 c-sections, 1,246 mothers not needing to transition to pharmacological treatments and saved 16,545 clinic visits. This represent a 60% increase in the number of women using GDm-Health since the full year results published in October 2018.    

 

SYNE

With the collaboration of our clinical partners, Sensyne has continued to develop the SYNE™ GDM/001 algorithm to identify mothers at risk of transitioning to medication therapy. With the guidance of our regulatory and quality team we are ready to deploy SYNE GDM/001 within GDm-Health at two NHS Trusts in early summer to complete our clinical deployment of this algorithm.

 

BPm-Health

The SP division has further strengthened its market position in the remote management of women patients during pregnancy with the development of BPm-Health, a prescribed digital therapeutic product for the remote monitoring of blood pressure during pregnancy, which was launched on 5 May 2020. The Company sees an interesting opportunity to build its franchise for remote monitoring applications in women’s health and is exploring further opportunities in this area.

 

Update on SP collaborations

The collaborations with Cognizant andMicrosoft that were established in late 2019 are delivering results as demonstrated by the rapid deployment of CVm-Health, accelerating the rate of development and deployment of software applications developed by the SP division and Sensyne expects these to underpin further progress and the entry of the Company’s products in the US market in the current financial year.

 

Sensyne’s high quality and robust regulatory framework

Sensyne has continued to invest in its quality and regulatory system framework for digital health applications andClinical AI to facilitate the development and launch of its clinically validated products and services in its two lead markets; the UK and US. This included a number of notable achievements that underpin the strength of the Company’s Quality Management System and information governance and compliance to Medical Device Directive, Medical Device Regulation and 21.CFR.820(US-FDA).  These include:

  • accreditation to ISO13485 (independently audited by BSI)
  • accreditation to ISO27001 (independently audited by BSI)
  • compliance to DSP Toolkit (NHS requirement for Information Governance compliance)
  • compliance to DCB0129 (NHS requirement for clinical risk management)
  • compliance to IG framework respecting GDPR requirements, Caldicott Principles and UK GovernmentCode of Conduct for Digital Health Technology
  • MHRA registration of GDm-Health, SEND and BPm-Health products
  • successful QMS transition to Medical Device Regulation (from Medical Device Directive) 1 year in advance of required transition deadline (May 2021)
  • undertook research with MHRA for a special project on “the creation of synthetic dataset for validation of AI algorithms”
  • listing in the NICE case studies for digital technologies
  • inclusion in the CQC regulatory sandbox for digital technologies

 

LAB10x partnership

The LAB10x partnership established during the year with Evotec, Oxford University Innovation, Oxford Sciences Innovation and the University of Oxford is working well with the first project now launched; ParkAI, a new software application for the management of Parkinson’s disease led by Prof Michelle Hu in the Nuffield Department of ClinicalNeurosciences, University of Oxford.

 

Strengthened management team

Over the period, Sensyne has strengthened its senior management team and grown total headcount in a very competitive market for talent.  105 people are employed by the Company as at 30 April 2020 (of which 57 have PhDs or similar postgraduate qualification).  Key appointments include:

  • Alan Payne as Chief Information Officer.  Alan has led global technology divisions for over 20 years for many multi-nationals including Aetna International, NuffieldHealth, JPMorganChase, Merrill Lynch, Oracle and AIG, and is an Honorary Professor in Intelligent Systems at UCL
  • Dr Lucy Mackillop as Chief Medical Officer, having been an advisor to the Company since October 2018. Lucy is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford
  • James Chandler as VP Communications, joining from BenevolentAI where he held the same role leading all marketing and communications
  • Laura Hillier, currently Legal Director (UK & Ireland) Pharmaceuticals GSK, will join Sensyne as General Counsel and Company Secretary on 1 August 2020. She has previously been Assistant General Counsel at ViiV Healthcare and a solicitor with Slaughter and May.
  • Sensyne has initiated the search for a new, permanent CFO with deep experience of public markets and corporate transactions in the UK and USA to reflect the Company’s future ambitions.

 

Corporate Governance

Following consultation with shareholders following the AGM in 2019 the Board has been progressing a number of matters to strengthen the Company’s corporate governance.

 

Chairman appointment

The Company is delighted to announce that Professor Sir Bruce Keogh KBE has agreed to become the permanent Chairman of the board of directors, having served as an independent director since 10 August 2018 and as interim Chairman since 10 December 2019. One of the UK’s leading doctors, Sir Bruce is Chairman of Birmingham Women’s and Children’s NHS Foundation Trust, having served as NHS England’s National Medical Director for 10 years where he was responsible for clinical leadership, quality and innovation. Before this he enjoyed a distinguished career in surgery, working as a consultant cardiac surgeon at University Hospitals Birmingham before becoming Director of Surgery at the Heart Hospital and Professor of CardiacSurgery at University College London.

Sir Bruce’s appointment to Chairman follows an external process to identify Chair candidates. Whilst a number of strong external candidates were considered, the Board concluded that Sir Bruce leading a Board further strengthened by additional independent non-executive directors was in the best interests of the Company.

 

Non-executive Directors

The Nomination Committee is actively seeking a Senior Independent Director, and two additional non-executive Directors to strengthen board committees. With the Chairman’s appointment now confirmed, the appointment of these additional non-executive Directors can now be completed, and further announcements on Board composition will be made in due course.

 

Remuneration policy for 2019/20 and2020/21

The Remuneration Committee undertook an extensive review of remuneration for the Company’s senior management team advised by Aon Consultants. The Remuneration Committee consulted with shareholders on the outcome of this review and revised Remuneration policies for 2019/20 and for 2020/21 were adopted by the Board following investor feedback. During this review period, Lord Drayson has received a salary of £1 per annum since 22 October 2019.  In line with the Company’s revised Remuneration policy, the basic salary for the CEO, Lord Drayson, for all of 2019/20 and for 2020/21 was set at £500,000 per annum. Not withstanding objective operational progress made throughout 2019/20, the Board and Lord Drayson have agreed that Lord Drayson will waive receipt of and not receive his performance related bonus for the full year 2019/20 in light of the COVID-19 pandemic and in recognition of the Company’s depressed share price.

 

Corporate Governance review

A&O Consultants were appointed to conduct an independent review of corporate governance and this work was completed and reported to the Board in January2020. The Company seeks to apply The UK Corporate Governance Code, the highest standard which is mandatory for listed companies and optional for AIM-quoted companies such as Sensyne. No significant breaches of, or gaps in, corporate governance were identified by the review although a number of areas for improvement of internal processes and communications were recommended. The Company is currently implementing these improvements.

Press release

Trading and Business Update

Trading and Business Update

May 14, 2020

Sensyne Health plc (LSE: SENS), the UK Clinical AI technology company, today announces a trading update (unaudited) for the year ended 30 April 2020. The Company will report its audited full year 2020 results in September 2020.

Highlights:

  • Strong revenue growth
  • Increasing demand for Sensyne remote monitoring products
  • GDm-Health, CVm-Health and BPm-Health products supplied free to NHS duringCOVID-19 pandemic
  • New commercial research agreement signed with Alexion
  • Appointment of Professor Sir Bruce Keogh KBE as permanent Chairman of the board of directors

Oxford, U.K. 14 May 2020:

The Company expects to report full year revenues of £2.1 million (FY19: £0.136 million), slightly ahead of guidance provided in January 2020 and largely driven by momentum in H2 2020.

Cash and cash equivalents were approximately £31.6 million (FY19: £49.3 million) reflecting continued investment in R&D.

COVID-19 has rapidly accelerated the adoption of digital technologies in healthcare systems around the world. Advancing patient care and accelerating the development of new medicines through the fusion of software, data science and machine learning technology with medical science are the very foundations of Sensyne Health.

The Company has a proven track record and embedded expert resource in these areas, particularly in remote patient monitoring and clinical AI. Consequently, Sensyne is seeing increasing demand for its products and technology as individuals, healthcare systems and the biopharmaceutical industry adapt to the current situation and make plans for a rapidly digitising healthcare future.

As such, The Company anticipates performing in line with the Board's expectations for the full year 2021 and the Board looks forward to the future of the Group with great confidence.

 

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:  

“Sensyne has adapted well to the changing environment brought on by COVID-19, is performing strongly and, whilst remaining prudent in light of the coronavirus pandemic, is well placed to deliver strong revenue growth during 2020/21.”  

Operational performance

 

COVID-19 and working with the NHS

The Company has continued to monitor and respond to the rapidly changing global situation, including guidance and policy changes implemented by governments around the world. Sensyne’s priority has been and continues to be on the health and wellbeing of its staff. The COVID-19 pandemic has had a major impact on NHS pressures, priorities and the allocation of NHS resources. Sensyne has not been directly affected negatively by the pandemic and has responded well by shifting the focus of its work in collaboration with its partner NHS Trusts in line with these changes, both in terms of supporting the shift to remote patient monitoring and in the use of Clinical AI. The Company has not furloughed any staff, nor has it participated in any of the other COVID-19 related government assistance schemes.

 

Sensyne responds with remote monitoring products during COVID-19

The Company has seen an acceleration in the adoption of tools by the NHS that enable remote monitoring of patients and this has led to increased demand and interest in the Company’s new and existing remote monitoring products including GDm-Health (diabetes in pregnancy monitoring), CVm-Health (remote COVID-19 symptom monitoring) and BPm-Health (blood pressure monitoring in pregnancy).   

The anonymised data sets generated by these products have in turn increased significantly. Sensyne expects that the recent growth in remote patient monitoring will be maintained post the pandemic and the Company is well placed to grow its business in this area in the future.

 

Progress with NHS agreements and achievement of research objectives

UK Government policy towards the use of patient data and the development of tools has changed significantly in recent months following the creation of NHSX and this change has accelerated in response to the pandemic, with NHSX focused on the development of the track & trace app and the creation of a central national database. The UK is increasingly centralising data assets under the control of NHSX and NHS Digital and, in addition to the pressures caused by the coronavirus pandemic, this is slowing the ability of NHS Trusts to enter into individual agreements with Sensyne. The Company is awaiting approval for agreements that it entered into in 2019 with Wye Valley and George Eliot NHS Trusts. The Company is currently in discussions with a number of additional NHS Trusts and discussions are taking longer than the Company has experienced previously. The projects with our existing partners Oxford University Hospitals, Chelsea & Westminster and South Warwickshire NHS Foundation Trusts are progressing well and the Company has been able to achieve its research objectives for its partners and customers.

 

Business re-organisation well positioned for growth

In Autumn 2019 Sensyne re-organised its business into two operating divisions, Discovery Sciences (DS) and Software Products (SP), to improve customer focus. The DS division focuses on providing services and products to pharmaceutical clients and the SP division focuses on providing services and products to healthcare providers such as the NHS. This re-organisation has been successfully implemented, led by the Company’s strengthened management team, and has led to an enhanced performance in H2 2020, providing Sensyne with a strong platform for growth, both organically and by potential acquisitions.

 

Discovery Sciences

Over the year, the DS division has grown to a team of more than 35 scientists with backgrounds in machine learning, bioinformatics and epidemiology, working closely with clinicians and biologists, to build a highly skilled interdisciplinary team.

In response to COVID-19, working in close co-operation with clinicians at Chelsea & Westminster NHS Foundation Trust, the DS team has developed algorithms using computer vision for the analysis of images to automatically detect COVID-19 in the lungs and algorithms to identify patients at risk of poor outcomes fromCOVID-19 infection based on analysis of EPR data.

 

Commercial research contract with Alexion

Sensyne has entered into a collaboration with Alexion, aNASDAQ listed global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. The collaboration will focus on studying the prevalence and outcomes of patients in disease areas of interest to Alexion Financial terms have not been disclosed.

 

Pharmapartnerships

With the recent addition of Alexion, the Company is working with 3 pharmaceutical companies, including Bayer and Roche. The work under these commercial research contracts has continued to progress well including during the coronavirus lockdown, but, as is common with these agreements, the Company is extremely limited in what it can report in terms of progress.  

Not withstanding the uncertainties caused by the COVID-19 pandemic, the Company’s business development activities continue.  Further updates will be provided as and when appropriate.  

 

 

Software Products

 

CVm-Health

CVm-Health, which is currently tailored towards COVID-19 response, is an app that was on the Company’s development roadmap for the future. Working effectively with Microsoft and Cognizant, the Company was able to develop and launch CVm-Health rapidly.  The CVm-Health ‘Good Neighbour’ app, was developed to provide a secure way for individuals to monitor and report the management of their health for COVID-19 related symptoms.  The strategy for  CVm-Health is to grow the platform both in the UK and internationally over time to be an effective system for remote monitoring of individuals of high risk to COVID-19.

CVm-Health was originally developed as a partnership product, but Sensyne launched CVm-Health as a free public service during the pandemic.  Since launch, functionality has been enhanced  through the addition of respiratory rate monitoring and the Health Diary, which enables users to see all recorded data for themselves and the people they monitor; soon users will be able to share this health diary with others, for example their healthcare provider.  In addition, given the vulnerability of the Black, Asian and minority ethnic community to COVID-19, the ability to add ethnicity data has been added. The next milestone will be the launch in theUSA. Technical development of the US version of CVm-Health will be completed later in May.  The ongoing aim forCVm-Health is to monitor specific population groups, in partnership with other organisations, and the Company continues to talk to organisations in the fields of health, social care and supported living. Recently, the Company has started to engage with employers and educational institutions who are looking for tools to support their management of employees and students who are returning after the coronavirus lockdown.

 

GDm-Health

The GDm-Health prescribed digital therapeutic product for the remote management of diabetes in pregnancy has been adopted by 10 new NHS Trusts going live in the past month bringing the total number of Trusts using GDm-Health to 23. A further 8 Trusts are awaiting ‘go-live’ and an additional 28 Trusts are in discussions to implement the system in their hospitals. The work with Jefferson Health for the clinical and economic evaluation of GDm-Health within a US hospital system is progressing well. The first clinical use of the product commenced in March 2020 and the product is on track for US launch, as planned, later in the financial year.

The benefit to patients and real-world impact in using GDm-Health continues to grow.  As at the year end, an extrapolation of results from the randomized controlled trial suggest use of GDm-Health should have prevented a total of 2,096 c-sections, 1,246 mothers not needing to transition to pharmacological treatments and saved 16,545 clinic visits. This represent a 60% increase in the number of women using GDm-Health since the full year results published in October 2018.    

 

SYNE

With the collaboration of our clinical partners, Sensyne has continued to develop the SYNE™ GDM/001 algorithm to identify mothers at risk of transitioning to medication therapy. With the guidance of our regulatory and quality team we are ready to deploy SYNE GDM/001 within GDm-Health at two NHS Trusts in early summer to complete our clinical deployment of this algorithm.

 

BPm-Health

The SP division has further strengthened its market position in the remote management of women patients during pregnancy with the development of BPm-Health, a prescribed digital therapeutic product for the remote monitoring of blood pressure during pregnancy, which was launched on 5 May 2020. The Company sees an interesting opportunity to build its franchise for remote monitoring applications in women’s health and is exploring further opportunities in this area.

 

Update on SP collaborations

The collaborations with Cognizant andMicrosoft that were established in late 2019 are delivering results as demonstrated by the rapid deployment of CVm-Health, accelerating the rate of development and deployment of software applications developed by the SP division and Sensyne expects these to underpin further progress and the entry of the Company’s products in the US market in the current financial year.

 

Sensyne’s high quality and robust regulatory framework

Sensyne has continued to invest in its quality and regulatory system framework for digital health applications andClinical AI to facilitate the development and launch of its clinically validated products and services in its two lead markets; the UK and US. This included a number of notable achievements that underpin the strength of the Company’s Quality Management System and information governance and compliance to Medical Device Directive, Medical Device Regulation and 21.CFR.820(US-FDA).  These include:

  • accreditation to ISO13485 (independently audited by BSI)
  • accreditation to ISO27001 (independently audited by BSI)
  • compliance to DSP Toolkit (NHS requirement for Information Governance compliance)
  • compliance to DCB0129 (NHS requirement for clinical risk management)
  • compliance to IG framework respecting GDPR requirements, Caldicott Principles and UK GovernmentCode of Conduct for Digital Health Technology
  • MHRA registration of GDm-Health, SEND and BPm-Health products
  • successful QMS transition to Medical Device Regulation (from Medical Device Directive) 1 year in advance of required transition deadline (May 2021)
  • undertook research with MHRA for a special project on “the creation of synthetic dataset for validation of AI algorithms”
  • listing in the NICE case studies for digital technologies
  • inclusion in the CQC regulatory sandbox for digital technologies

 

LAB10x partnership

The LAB10x partnership established during the year with Evotec, Oxford University Innovation, Oxford Sciences Innovation and the University of Oxford is working well with the first project now launched; ParkAI, a new software application for the management of Parkinson’s disease led by Prof Michelle Hu in the Nuffield Department of ClinicalNeurosciences, University of Oxford.

 

Strengthened management team

Over the period, Sensyne has strengthened its senior management team and grown total headcount in a very competitive market for talent.  105 people are employed by the Company as at 30 April 2020 (of which 57 have PhDs or similar postgraduate qualification).  Key appointments include:

  • Alan Payne as Chief Information Officer.  Alan has led global technology divisions for over 20 years for many multi-nationals including Aetna International, NuffieldHealth, JPMorganChase, Merrill Lynch, Oracle and AIG, and is an Honorary Professor in Intelligent Systems at UCL
  • Dr Lucy Mackillop as Chief Medical Officer, having been an advisor to the Company since October 2018. Lucy is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford
  • James Chandler as VP Communications, joining from BenevolentAI where he held the same role leading all marketing and communications
  • Laura Hillier, currently Legal Director (UK & Ireland) Pharmaceuticals GSK, will join Sensyne as General Counsel and Company Secretary on 1 August 2020. She has previously been Assistant General Counsel at ViiV Healthcare and a solicitor with Slaughter and May.
  • Sensyne has initiated the search for a new, permanent CFO with deep experience of public markets and corporate transactions in the UK and USA to reflect the Company’s future ambitions.

 

Corporate Governance

Following consultation with shareholders following the AGM in 2019 the Board has been progressing a number of matters to strengthen the Company’s corporate governance.

 

Chairman appointment

The Company is delighted to announce that Professor Sir Bruce Keogh KBE has agreed to become the permanent Chairman of the board of directors, having served as an independent director since 10 August 2018 and as interim Chairman since 10 December 2019. One of the UK’s leading doctors, Sir Bruce is Chairman of Birmingham Women’s and Children’s NHS Foundation Trust, having served as NHS England’s National Medical Director for 10 years where he was responsible for clinical leadership, quality and innovation. Before this he enjoyed a distinguished career in surgery, working as a consultant cardiac surgeon at University Hospitals Birmingham before becoming Director of Surgery at the Heart Hospital and Professor of CardiacSurgery at University College London.

Sir Bruce’s appointment to Chairman follows an external process to identify Chair candidates. Whilst a number of strong external candidates were considered, the Board concluded that Sir Bruce leading a Board further strengthened by additional independent non-executive directors was in the best interests of the Company.

 

Non-executive Directors

The Nomination Committee is actively seeking a Senior Independent Director, and two additional non-executive Directors to strengthen board committees. With the Chairman’s appointment now confirmed, the appointment of these additional non-executive Directors can now be completed, and further announcements on Board composition will be made in due course.

 

Remuneration policy for 2019/20 and2020/21

The Remuneration Committee undertook an extensive review of remuneration for the Company’s senior management team advised by Aon Consultants. The Remuneration Committee consulted with shareholders on the outcome of this review and revised Remuneration policies for 2019/20 and for 2020/21 were adopted by the Board following investor feedback. During this review period, Lord Drayson has received a salary of £1 per annum since 22 October 2019.  In line with the Company’s revised Remuneration policy, the basic salary for the CEO, Lord Drayson, for all of 2019/20 and for 2020/21 was set at £500,000 per annum. Not withstanding objective operational progress made throughout 2019/20, the Board and Lord Drayson have agreed that Lord Drayson will waive receipt of and not receive his performance related bonus for the full year 2019/20 in light of the COVID-19 pandemic and in recognition of the Company’s depressed share price.

 

Corporate Governance review

A&O Consultants were appointed to conduct an independent review of corporate governance and this work was completed and reported to the Board in January2020. The Company seeks to apply The UK Corporate Governance Code, the highest standard which is mandatory for listed companies and optional for AIM-quoted companies such as Sensyne. No significant breaches of, or gaps in, corporate governance were identified by the review although a number of areas for improvement of internal processes and communications were recommended. The Company is currently implementing these improvements.

Press release

Trading and Business Update

Trading and Business Update

Sensyne Health plc (LSE: SENS), the UK Clinical AI technology company, today announces a trading update (unaudited) for the year ended 30 April 2020. The Company will report its audited full year 2020 results in September 2020.

Highlights:

  • Strong revenue growth
  • Increasing demand for Sensyne remote monitoring products
  • GDm-Health, CVm-Health and BPm-Health products supplied free to NHS duringCOVID-19 pandemic
  • New commercial research agreement signed with Alexion
  • Appointment of Professor Sir Bruce Keogh KBE as permanent Chairman of the board of directors

Oxford, U.K. 14 May 2020:

The Company expects to report full year revenues of £2.1 million (FY19: £0.136 million), slightly ahead of guidance provided in January 2020 and largely driven by momentum in H2 2020.

Cash and cash equivalents were approximately £31.6 million (FY19: £49.3 million) reflecting continued investment in R&D.

COVID-19 has rapidly accelerated the adoption of digital technologies in healthcare systems around the world. Advancing patient care and accelerating the development of new medicines through the fusion of software, data science and machine learning technology with medical science are the very foundations of Sensyne Health.

The Company has a proven track record and embedded expert resource in these areas, particularly in remote patient monitoring and clinical AI. Consequently, Sensyne is seeing increasing demand for its products and technology as individuals, healthcare systems and the biopharmaceutical industry adapt to the current situation and make plans for a rapidly digitising healthcare future.

As such, The Company anticipates performing in line with the Board's expectations for the full year 2021 and the Board looks forward to the future of the Group with great confidence.

 

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:  

“Sensyne has adapted well to the changing environment brought on by COVID-19, is performing strongly and, whilst remaining prudent in light of the coronavirus pandemic, is well placed to deliver strong revenue growth during 2020/21.”  

Operational performance

 

COVID-19 and working with the NHS

The Company has continued to monitor and respond to the rapidly changing global situation, including guidance and policy changes implemented by governments around the world. Sensyne’s priority has been and continues to be on the health and wellbeing of its staff. The COVID-19 pandemic has had a major impact on NHS pressures, priorities and the allocation of NHS resources. Sensyne has not been directly affected negatively by the pandemic and has responded well by shifting the focus of its work in collaboration with its partner NHS Trusts in line with these changes, both in terms of supporting the shift to remote patient monitoring and in the use of Clinical AI. The Company has not furloughed any staff, nor has it participated in any of the other COVID-19 related government assistance schemes.

 

Sensyne responds with remote monitoring products during COVID-19

The Company has seen an acceleration in the adoption of tools by the NHS that enable remote monitoring of patients and this has led to increased demand and interest in the Company’s new and existing remote monitoring products including GDm-Health (diabetes in pregnancy monitoring), CVm-Health (remote COVID-19 symptom monitoring) and BPm-Health (blood pressure monitoring in pregnancy).   

The anonymised data sets generated by these products have in turn increased significantly. Sensyne expects that the recent growth in remote patient monitoring will be maintained post the pandemic and the Company is well placed to grow its business in this area in the future.

 

Progress with NHS agreements and achievement of research objectives

UK Government policy towards the use of patient data and the development of tools has changed significantly in recent months following the creation of NHSX and this change has accelerated in response to the pandemic, with NHSX focused on the development of the track & trace app and the creation of a central national database. The UK is increasingly centralising data assets under the control of NHSX and NHS Digital and, in addition to the pressures caused by the coronavirus pandemic, this is slowing the ability of NHS Trusts to enter into individual agreements with Sensyne. The Company is awaiting approval for agreements that it entered into in 2019 with Wye Valley and George Eliot NHS Trusts. The Company is currently in discussions with a number of additional NHS Trusts and discussions are taking longer than the Company has experienced previously. The projects with our existing partners Oxford University Hospitals, Chelsea & Westminster and South Warwickshire NHS Foundation Trusts are progressing well and the Company has been able to achieve its research objectives for its partners and customers.

 

Business re-organisation well positioned for growth

In Autumn 2019 Sensyne re-organised its business into two operating divisions, Discovery Sciences (DS) and Software Products (SP), to improve customer focus. The DS division focuses on providing services and products to pharmaceutical clients and the SP division focuses on providing services and products to healthcare providers such as the NHS. This re-organisation has been successfully implemented, led by the Company’s strengthened management team, and has led to an enhanced performance in H2 2020, providing Sensyne with a strong platform for growth, both organically and by potential acquisitions.

 

Discovery Sciences

Over the year, the DS division has grown to a team of more than 35 scientists with backgrounds in machine learning, bioinformatics and epidemiology, working closely with clinicians and biologists, to build a highly skilled interdisciplinary team.

In response to COVID-19, working in close co-operation with clinicians at Chelsea & Westminster NHS Foundation Trust, the DS team has developed algorithms using computer vision for the analysis of images to automatically detect COVID-19 in the lungs and algorithms to identify patients at risk of poor outcomes fromCOVID-19 infection based on analysis of EPR data.

 

Commercial research contract with Alexion

Sensyne has entered into a collaboration with Alexion, aNASDAQ listed global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. The collaboration will focus on studying the prevalence and outcomes of patients in disease areas of interest to Alexion Financial terms have not been disclosed.

 

Pharmapartnerships

With the recent addition of Alexion, the Company is working with 3 pharmaceutical companies, including Bayer and Roche. The work under these commercial research contracts has continued to progress well including during the coronavirus lockdown, but, as is common with these agreements, the Company is extremely limited in what it can report in terms of progress.  

Not withstanding the uncertainties caused by the COVID-19 pandemic, the Company’s business development activities continue.  Further updates will be provided as and when appropriate.  

 

 

Software Products

 

CVm-Health

CVm-Health, which is currently tailored towards COVID-19 response, is an app that was on the Company’s development roadmap for the future. Working effectively with Microsoft and Cognizant, the Company was able to develop and launch CVm-Health rapidly.  The CVm-Health ‘Good Neighbour’ app, was developed to provide a secure way for individuals to monitor and report the management of their health for COVID-19 related symptoms.  The strategy for  CVm-Health is to grow the platform both in the UK and internationally over time to be an effective system for remote monitoring of individuals of high risk to COVID-19.

CVm-Health was originally developed as a partnership product, but Sensyne launched CVm-Health as a free public service during the pandemic.  Since launch, functionality has been enhanced  through the addition of respiratory rate monitoring and the Health Diary, which enables users to see all recorded data for themselves and the people they monitor; soon users will be able to share this health diary with others, for example their healthcare provider.  In addition, given the vulnerability of the Black, Asian and minority ethnic community to COVID-19, the ability to add ethnicity data has been added. The next milestone will be the launch in theUSA. Technical development of the US version of CVm-Health will be completed later in May.  The ongoing aim forCVm-Health is to monitor specific population groups, in partnership with other organisations, and the Company continues to talk to organisations in the fields of health, social care and supported living. Recently, the Company has started to engage with employers and educational institutions who are looking for tools to support their management of employees and students who are returning after the coronavirus lockdown.

 

GDm-Health

The GDm-Health prescribed digital therapeutic product for the remote management of diabetes in pregnancy has been adopted by 10 new NHS Trusts going live in the past month bringing the total number of Trusts using GDm-Health to 23. A further 8 Trusts are awaiting ‘go-live’ and an additional 28 Trusts are in discussions to implement the system in their hospitals. The work with Jefferson Health for the clinical and economic evaluation of GDm-Health within a US hospital system is progressing well. The first clinical use of the product commenced in March 2020 and the product is on track for US launch, as planned, later in the financial year.

The benefit to patients and real-world impact in using GDm-Health continues to grow.  As at the year end, an extrapolation of results from the randomized controlled trial suggest use of GDm-Health should have prevented a total of 2,096 c-sections, 1,246 mothers not needing to transition to pharmacological treatments and saved 16,545 clinic visits. This represent a 60% increase in the number of women using GDm-Health since the full year results published in October 2018.    

 

SYNE

With the collaboration of our clinical partners, Sensyne has continued to develop the SYNE™ GDM/001 algorithm to identify mothers at risk of transitioning to medication therapy. With the guidance of our regulatory and quality team we are ready to deploy SYNE GDM/001 within GDm-Health at two NHS Trusts in early summer to complete our clinical deployment of this algorithm.

 

BPm-Health

The SP division has further strengthened its market position in the remote management of women patients during pregnancy with the development of BPm-Health, a prescribed digital therapeutic product for the remote monitoring of blood pressure during pregnancy, which was launched on 5 May 2020. The Company sees an interesting opportunity to build its franchise for remote monitoring applications in women’s health and is exploring further opportunities in this area.

 

Update on SP collaborations

The collaborations with Cognizant andMicrosoft that were established in late 2019 are delivering results as demonstrated by the rapid deployment of CVm-Health, accelerating the rate of development and deployment of software applications developed by the SP division and Sensyne expects these to underpin further progress and the entry of the Company’s products in the US market in the current financial year.

 

Sensyne’s high quality and robust regulatory framework

Sensyne has continued to invest in its quality and regulatory system framework for digital health applications andClinical AI to facilitate the development and launch of its clinically validated products and services in its two lead markets; the UK and US. This included a number of notable achievements that underpin the strength of the Company’s Quality Management System and information governance and compliance to Medical Device Directive, Medical Device Regulation and 21.CFR.820(US-FDA).  These include:

  • accreditation to ISO13485 (independently audited by BSI)
  • accreditation to ISO27001 (independently audited by BSI)
  • compliance to DSP Toolkit (NHS requirement for Information Governance compliance)
  • compliance to DCB0129 (NHS requirement for clinical risk management)
  • compliance to IG framework respecting GDPR requirements, Caldicott Principles and UK GovernmentCode of Conduct for Digital Health Technology
  • MHRA registration of GDm-Health, SEND and BPm-Health products
  • successful QMS transition to Medical Device Regulation (from Medical Device Directive) 1 year in advance of required transition deadline (May 2021)
  • undertook research with MHRA for a special project on “the creation of synthetic dataset for validation of AI algorithms”
  • listing in the NICE case studies for digital technologies
  • inclusion in the CQC regulatory sandbox for digital technologies

 

LAB10x partnership

The LAB10x partnership established during the year with Evotec, Oxford University Innovation, Oxford Sciences Innovation and the University of Oxford is working well with the first project now launched; ParkAI, a new software application for the management of Parkinson’s disease led by Prof Michelle Hu in the Nuffield Department of ClinicalNeurosciences, University of Oxford.

 

Strengthened management team

Over the period, Sensyne has strengthened its senior management team and grown total headcount in a very competitive market for talent.  105 people are employed by the Company as at 30 April 2020 (of which 57 have PhDs or similar postgraduate qualification).  Key appointments include:

  • Alan Payne as Chief Information Officer.  Alan has led global technology divisions for over 20 years for many multi-nationals including Aetna International, NuffieldHealth, JPMorganChase, Merrill Lynch, Oracle and AIG, and is an Honorary Professor in Intelligent Systems at UCL
  • Dr Lucy Mackillop as Chief Medical Officer, having been an advisor to the Company since October 2018. Lucy is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford
  • James Chandler as VP Communications, joining from BenevolentAI where he held the same role leading all marketing and communications
  • Laura Hillier, currently Legal Director (UK & Ireland) Pharmaceuticals GSK, will join Sensyne as General Counsel and Company Secretary on 1 August 2020. She has previously been Assistant General Counsel at ViiV Healthcare and a solicitor with Slaughter and May.
  • Sensyne has initiated the search for a new, permanent CFO with deep experience of public markets and corporate transactions in the UK and USA to reflect the Company’s future ambitions.

 

Corporate Governance

Following consultation with shareholders following the AGM in 2019 the Board has been progressing a number of matters to strengthen the Company’s corporate governance.

 

Chairman appointment

The Company is delighted to announce that Professor Sir Bruce Keogh KBE has agreed to become the permanent Chairman of the board of directors, having served as an independent director since 10 August 2018 and as interim Chairman since 10 December 2019. One of the UK’s leading doctors, Sir Bruce is Chairman of Birmingham Women’s and Children’s NHS Foundation Trust, having served as NHS England’s National Medical Director for 10 years where he was responsible for clinical leadership, quality and innovation. Before this he enjoyed a distinguished career in surgery, working as a consultant cardiac surgeon at University Hospitals Birmingham before becoming Director of Surgery at the Heart Hospital and Professor of CardiacSurgery at University College London.

Sir Bruce’s appointment to Chairman follows an external process to identify Chair candidates. Whilst a number of strong external candidates were considered, the Board concluded that Sir Bruce leading a Board further strengthened by additional independent non-executive directors was in the best interests of the Company.

 

Non-executive Directors

The Nomination Committee is actively seeking a Senior Independent Director, and two additional non-executive Directors to strengthen board committees. With the Chairman’s appointment now confirmed, the appointment of these additional non-executive Directors can now be completed, and further announcements on Board composition will be made in due course.

 

Remuneration policy for 2019/20 and2020/21

The Remuneration Committee undertook an extensive review of remuneration for the Company’s senior management team advised by Aon Consultants. The Remuneration Committee consulted with shareholders on the outcome of this review and revised Remuneration policies for 2019/20 and for 2020/21 were adopted by the Board following investor feedback. During this review period, Lord Drayson has received a salary of £1 per annum since 22 October 2019.  In line with the Company’s revised Remuneration policy, the basic salary for the CEO, Lord Drayson, for all of 2019/20 and for 2020/21 was set at £500,000 per annum. Not withstanding objective operational progress made throughout 2019/20, the Board and Lord Drayson have agreed that Lord Drayson will waive receipt of and not receive his performance related bonus for the full year 2019/20 in light of the COVID-19 pandemic and in recognition of the Company’s depressed share price.

 

Corporate Governance review

A&O Consultants were appointed to conduct an independent review of corporate governance and this work was completed and reported to the Board in January2020. The Company seeks to apply The UK Corporate Governance Code, the highest standard which is mandatory for listed companies and optional for AIM-quoted companies such as Sensyne. No significant breaches of, or gaps in, corporate governance were identified by the review although a number of areas for improvement of internal processes and communications were recommended. The Company is currently implementing these improvements.

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Press release

Trading and Business Update

May 14, 2020

Sensyne Health plc (LSE: SENS), the UK Clinical AI technology company, today announces a trading update (unaudited) for the year ended 30 April 2020. The Company will report its audited full year 2020 results in September 2020.

Highlights:

  • Strong revenue growth
  • Increasing demand for Sensyne remote monitoring products
  • GDm-Health, CVm-Health and BPm-Health products supplied free to NHS duringCOVID-19 pandemic
  • New commercial research agreement signed with Alexion
  • Appointment of Professor Sir Bruce Keogh KBE as permanent Chairman of the board of directors

Oxford, U.K. 14 May 2020:

The Company expects to report full year revenues of £2.1 million (FY19: £0.136 million), slightly ahead of guidance provided in January 2020 and largely driven by momentum in H2 2020.

Cash and cash equivalents were approximately £31.6 million (FY19: £49.3 million) reflecting continued investment in R&D.

COVID-19 has rapidly accelerated the adoption of digital technologies in healthcare systems around the world. Advancing patient care and accelerating the development of new medicines through the fusion of software, data science and machine learning technology with medical science are the very foundations of Sensyne Health.

The Company has a proven track record and embedded expert resource in these areas, particularly in remote patient monitoring and clinical AI. Consequently, Sensyne is seeing increasing demand for its products and technology as individuals, healthcare systems and the biopharmaceutical industry adapt to the current situation and make plans for a rapidly digitising healthcare future.

As such, The Company anticipates performing in line with the Board's expectations for the full year 2021 and the Board looks forward to the future of the Group with great confidence.

 

Lord (Paul) Drayson PhD, CEO of Sensyne Health, said:  

“Sensyne has adapted well to the changing environment brought on by COVID-19, is performing strongly and, whilst remaining prudent in light of the coronavirus pandemic, is well placed to deliver strong revenue growth during 2020/21.”  

Operational performance

 

COVID-19 and working with the NHS

The Company has continued to monitor and respond to the rapidly changing global situation, including guidance and policy changes implemented by governments around the world. Sensyne’s priority has been and continues to be on the health and wellbeing of its staff. The COVID-19 pandemic has had a major impact on NHS pressures, priorities and the allocation of NHS resources. Sensyne has not been directly affected negatively by the pandemic and has responded well by shifting the focus of its work in collaboration with its partner NHS Trusts in line with these changes, both in terms of supporting the shift to remote patient monitoring and in the use of Clinical AI. The Company has not furloughed any staff, nor has it participated in any of the other COVID-19 related government assistance schemes.

 

Sensyne responds with remote monitoring products during COVID-19

The Company has seen an acceleration in the adoption of tools by the NHS that enable remote monitoring of patients and this has led to increased demand and interest in the Company’s new and existing remote monitoring products including GDm-Health (diabetes in pregnancy monitoring), CVm-Health (remote COVID-19 symptom monitoring) and BPm-Health (blood pressure monitoring in pregnancy).   

The anonymised data sets generated by these products have in turn increased significantly. Sensyne expects that the recent growth in remote patient monitoring will be maintained post the pandemic and the Company is well placed to grow its business in this area in the future.

 

Progress with NHS agreements and achievement of research objectives

UK Government policy towards the use of patient data and the development of tools has changed significantly in recent months following the creation of NHSX and this change has accelerated in response to the pandemic, with NHSX focused on the development of the track & trace app and the creation of a central national database. The UK is increasingly centralising data assets under the control of NHSX and NHS Digital and, in addition to the pressures caused by the coronavirus pandemic, this is slowing the ability of NHS Trusts to enter into individual agreements with Sensyne. The Company is awaiting approval for agreements that it entered into in 2019 with Wye Valley and George Eliot NHS Trusts. The Company is currently in discussions with a number of additional NHS Trusts and discussions are taking longer than the Company has experienced previously. The projects with our existing partners Oxford University Hospitals, Chelsea & Westminster and South Warwickshire NHS Foundation Trusts are progressing well and the Company has been able to achieve its research objectives for its partners and customers.

 

Business re-organisation well positioned for growth

In Autumn 2019 Sensyne re-organised its business into two operating divisions, Discovery Sciences (DS) and Software Products (SP), to improve customer focus. The DS division focuses on providing services and products to pharmaceutical clients and the SP division focuses on providing services and products to healthcare providers such as the NHS. This re-organisation has been successfully implemented, led by the Company’s strengthened management team, and has led to an enhanced performance in H2 2020, providing Sensyne with a strong platform for growth, both organically and by potential acquisitions.

 

Discovery Sciences

Over the year, the DS division has grown to a team of more than 35 scientists with backgrounds in machine learning, bioinformatics and epidemiology, working closely with clinicians and biologists, to build a highly skilled interdisciplinary team.

In response to COVID-19, working in close co-operation with clinicians at Chelsea & Westminster NHS Foundation Trust, the DS team has developed algorithms using computer vision for the analysis of images to automatically detect COVID-19 in the lungs and algorithms to identify patients at risk of poor outcomes fromCOVID-19 infection based on analysis of EPR data.

 

Commercial research contract with Alexion

Sensyne has entered into a collaboration with Alexion, aNASDAQ listed global biopharmaceutical company focused on developing life-changing therapies for people living with rare disorders. The collaboration will focus on studying the prevalence and outcomes of patients in disease areas of interest to Alexion Financial terms have not been disclosed.

 

Pharmapartnerships

With the recent addition of Alexion, the Company is working with 3 pharmaceutical companies, including Bayer and Roche. The work under these commercial research contracts has continued to progress well including during the coronavirus lockdown, but, as is common with these agreements, the Company is extremely limited in what it can report in terms of progress.  

Not withstanding the uncertainties caused by the COVID-19 pandemic, the Company’s business development activities continue.  Further updates will be provided as and when appropriate.  

 

 

Software Products

 

CVm-Health

CVm-Health, which is currently tailored towards COVID-19 response, is an app that was on the Company’s development roadmap for the future. Working effectively with Microsoft and Cognizant, the Company was able to develop and launch CVm-Health rapidly.  The CVm-Health ‘Good Neighbour’ app, was developed to provide a secure way for individuals to monitor and report the management of their health for COVID-19 related symptoms.  The strategy for  CVm-Health is to grow the platform both in the UK and internationally over time to be an effective system for remote monitoring of individuals of high risk to COVID-19.

CVm-Health was originally developed as a partnership product, but Sensyne launched CVm-Health as a free public service during the pandemic.  Since launch, functionality has been enhanced  through the addition of respiratory rate monitoring and the Health Diary, which enables users to see all recorded data for themselves and the people they monitor; soon users will be able to share this health diary with others, for example their healthcare provider.  In addition, given the vulnerability of the Black, Asian and minority ethnic community to COVID-19, the ability to add ethnicity data has been added. The next milestone will be the launch in theUSA. Technical development of the US version of CVm-Health will be completed later in May.  The ongoing aim forCVm-Health is to monitor specific population groups, in partnership with other organisations, and the Company continues to talk to organisations in the fields of health, social care and supported living. Recently, the Company has started to engage with employers and educational institutions who are looking for tools to support their management of employees and students who are returning after the coronavirus lockdown.

 

GDm-Health

The GDm-Health prescribed digital therapeutic product for the remote management of diabetes in pregnancy has been adopted by 10 new NHS Trusts going live in the past month bringing the total number of Trusts using GDm-Health to 23. A further 8 Trusts are awaiting ‘go-live’ and an additional 28 Trusts are in discussions to implement the system in their hospitals. The work with Jefferson Health for the clinical and economic evaluation of GDm-Health within a US hospital system is progressing well. The first clinical use of the product commenced in March 2020 and the product is on track for US launch, as planned, later in the financial year.

The benefit to patients and real-world impact in using GDm-Health continues to grow.  As at the year end, an extrapolation of results from the randomized controlled trial suggest use of GDm-Health should have prevented a total of 2,096 c-sections, 1,246 mothers not needing to transition to pharmacological treatments and saved 16,545 clinic visits. This represent a 60% increase in the number of women using GDm-Health since the full year results published in October 2018.    

 

SYNE

With the collaboration of our clinical partners, Sensyne has continued to develop the SYNE™ GDM/001 algorithm to identify mothers at risk of transitioning to medication therapy. With the guidance of our regulatory and quality team we are ready to deploy SYNE GDM/001 within GDm-Health at two NHS Trusts in early summer to complete our clinical deployment of this algorithm.

 

BPm-Health

The SP division has further strengthened its market position in the remote management of women patients during pregnancy with the development of BPm-Health, a prescribed digital therapeutic product for the remote monitoring of blood pressure during pregnancy, which was launched on 5 May 2020. The Company sees an interesting opportunity to build its franchise for remote monitoring applications in women’s health and is exploring further opportunities in this area.

 

Update on SP collaborations

The collaborations with Cognizant andMicrosoft that were established in late 2019 are delivering results as demonstrated by the rapid deployment of CVm-Health, accelerating the rate of development and deployment of software applications developed by the SP division and Sensyne expects these to underpin further progress and the entry of the Company’s products in the US market in the current financial year.

 

Sensyne’s high quality and robust regulatory framework

Sensyne has continued to invest in its quality and regulatory system framework for digital health applications andClinical AI to facilitate the development and launch of its clinically validated products and services in its two lead markets; the UK and US. This included a number of notable achievements that underpin the strength of the Company’s Quality Management System and information governance and compliance to Medical Device Directive, Medical Device Regulation and 21.CFR.820(US-FDA).  These include:

  • accreditation to ISO13485 (independently audited by BSI)
  • accreditation to ISO27001 (independently audited by BSI)
  • compliance to DSP Toolkit (NHS requirement for Information Governance compliance)
  • compliance to DCB0129 (NHS requirement for clinical risk management)
  • compliance to IG framework respecting GDPR requirements, Caldicott Principles and UK GovernmentCode of Conduct for Digital Health Technology
  • MHRA registration of GDm-Health, SEND and BPm-Health products
  • successful QMS transition to Medical Device Regulation (from Medical Device Directive) 1 year in advance of required transition deadline (May 2021)
  • undertook research with MHRA for a special project on “the creation of synthetic dataset for validation of AI algorithms”
  • listing in the NICE case studies for digital technologies
  • inclusion in the CQC regulatory sandbox for digital technologies

 

LAB10x partnership

The LAB10x partnership established during the year with Evotec, Oxford University Innovation, Oxford Sciences Innovation and the University of Oxford is working well with the first project now launched; ParkAI, a new software application for the management of Parkinson’s disease led by Prof Michelle Hu in the Nuffield Department of ClinicalNeurosciences, University of Oxford.

 

Strengthened management team

Over the period, Sensyne has strengthened its senior management team and grown total headcount in a very competitive market for talent.  105 people are employed by the Company as at 30 April 2020 (of which 57 have PhDs or similar postgraduate qualification).  Key appointments include:

  • Alan Payne as Chief Information Officer.  Alan has led global technology divisions for over 20 years for many multi-nationals including Aetna International, NuffieldHealth, JPMorganChase, Merrill Lynch, Oracle and AIG, and is an Honorary Professor in Intelligent Systems at UCL
  • Dr Lucy Mackillop as Chief Medical Officer, having been an advisor to the Company since October 2018. Lucy is a consultant obstetric physician at Oxford University Hospitals NHS Foundation Trust and Honorary Senior Clinical Lecturer, Nuffield Department of Women’s and Reproductive Health, University of Oxford
  • James Chandler as VP Communications, joining from BenevolentAI where he held the same role leading all marketing and communications
  • Laura Hillier, currently Legal Director (UK & Ireland) Pharmaceuticals GSK, will join Sensyne as General Counsel and Company Secretary on 1 August 2020. She has previously been Assistant General Counsel at ViiV Healthcare and a solicitor with Slaughter and May.
  • Sensyne has initiated the search for a new, permanent CFO with deep experience of public markets and corporate transactions in the UK and USA to reflect the Company’s future ambitions.

 

Corporate Governance

Following consultation with shareholders following the AGM in 2019 the Board has been progressing a number of matters to strengthen the Company’s corporate governance.

 

Chairman appointment

The Company is delighted to announce that Professor Sir Bruce Keogh KBE has agreed to become the permanent Chairman of the board of directors, having served as an independent director since 10 August 2018 and as interim Chairman since 10 December 2019. One of the UK’s leading doctors, Sir Bruce is Chairman of Birmingham Women’s and Children’s NHS Foundation Trust, having served as NHS England’s National Medical Director for 10 years where he was responsible for clinical leadership, quality and innovation. Before this he enjoyed a distinguished career in surgery, working as a consultant cardiac surgeon at University Hospitals Birmingham before becoming Director of Surgery at the Heart Hospital and Professor of CardiacSurgery at University College London.

Sir Bruce’s appointment to Chairman follows an external process to identify Chair candidates. Whilst a number of strong external candidates were considered, the Board concluded that Sir Bruce leading a Board further strengthened by additional independent non-executive directors was in the best interests of the Company.

 

Non-executive Directors

The Nomination Committee is actively seeking a Senior Independent Director, and two additional non-executive Directors to strengthen board committees. With the Chairman’s appointment now confirmed, the appointment of these additional non-executive Directors can now be completed, and further announcements on Board composition will be made in due course.

 

Remuneration policy for 2019/20 and2020/21

The Remuneration Committee undertook an extensive review of remuneration for the Company’s senior management team advised by Aon Consultants. The Remuneration Committee consulted with shareholders on the outcome of this review and revised Remuneration policies for 2019/20 and for 2020/21 were adopted by the Board following investor feedback. During this review period, Lord Drayson has received a salary of £1 per annum since 22 October 2019.  In line with the Company’s revised Remuneration policy, the basic salary for the CEO, Lord Drayson, for all of 2019/20 and for 2020/21 was set at £500,000 per annum. Not withstanding objective operational progress made throughout 2019/20, the Board and Lord Drayson have agreed that Lord Drayson will waive receipt of and not receive his performance related bonus for the full year 2019/20 in light of the COVID-19 pandemic and in recognition of the Company’s depressed share price.

 

Corporate Governance review

A&O Consultants were appointed to conduct an independent review of corporate governance and this work was completed and reported to the Board in January2020. The Company seeks to apply The UK Corporate Governance Code, the highest standard which is mandatory for listed companies and optional for AIM-quoted companies such as Sensyne. No significant breaches of, or gaps in, corporate governance were identified by the review although a number of areas for improvement of internal processes and communications were recommended. The Company is currently implementing these improvements.