Developing stem
cell technologies to
improve patients' lives
ReNeuron Group plc
Annual Report and Accounts 2021
Inside our report
Introduction
A snapshot of our year | 2 |
Financial Highlights | 3 |
Group at a glance | 4 |
Chairman's statement | 7 |
Strategic Report
Our marketplace | 10 |
Our business model | 15 |
Our progress for developing | |
life-changing therapies | 16 |
Our progress towards | |
changing patients' lives | 18 |
Chief Executive Officer's | |
review of performance | 24 |
Financial review | 27 |
Directors' duties | 28 |
Sustainability | 29 |
Risks and uncertainties | 30 |
Governance
Board of directors | 34 |
Senior management | 36 |
Directors' report | 38 |
Corporate governance | 40 |
Audit committee report | 46 |
Directors' remuneration report | 48 |
Financial Statements
Independent auditors' report | 57 |
Group statement of | |
comprehensive income | 62 |
Group and Parent Company | |
statements of financial position | 63 |
Group and Parent Company | |
statements of changes in equity | 64 |
Group and Parent Company | |
statements of cash flows | 65 |
Notes to the financial statements | 66 |
Annual General Meeting
Notice of annual general meeting | 89 |
Explanatory notes to the business | |
of the annual general meeting | 92 |
Other Information
Welcome to our 2021 Annual Report
As a leader in cell-based therapeutics, we develop allogeneic stem cell technology platforms, stem cell derived exosomes and induced pluripotent stem cells (iPSCs).
Advisers | 93 |
Shareholder information | 93 |
Glossary of scientific terms | 94 |
Introduction
Our vision is to improve patients' lives through our proprietary stem cell technologies.
Who we are
We are a UK-based global leader in the development of cell-based therapeutics, harnessing our technologies to develop 'off the shelf' treatments for diseases with significant unmet needs.
Read more
See our group at a glance on pages 4 to 5
What we do
Our lead cell therapy candidate is in clinical development for retinitis pigmentosa and we are advancing our exosomes and induced pluripotent stem cell (iPSC) platform technologies.
See our business model on page 15
Our technology
Our lead stem cell therapy candidate is cryopreserved allowing global ship-and-store and is not dependent on genetic cause.
Our proprietary exosomes and iPSC platform technologies have potential in a multiple of therapeutic areas.
Read about our competitive advantages on page 6
ReNeuron Annual Report for the year ended 31 March 2021 01
A snapshot of our year
iPSCs
Exosome
hRPC for retinal nanomedicine
diseasesplatform
iPSC platform
Leading programme with Orphan Drug Designation in EU and US in RP and FDA Fast Track Designation
Our progress to date
- Efficacy signal seen in phase 2a subjects reaching 12 months follow up with some variability of response seen between subjects.
- Regulatory approval has been received for the expanded Phase 2a study in US, UK and Spain. This Phase 2a extension study incorporates a doubling of the previous dose, which with other study elements was designed to build on the efficacy signal seen in the earlier cohorts of the study whilst trying to remove some of the variability.
-
Four out of the nine additional subjects have been treated to date but a presumed case of bacterial endophthalmitis led to precautionary temporary study enrolment suspension. However, following a completed investigation, and with Data
& Safety Monitoring Board approval, the study has reopened to enrolment in the US with amendments being filed to reopen in the UK and Spain. - Three-monthdata from extension segment of Phase 2a study to be available in Q4 2021.
Future milestones and high value opportunities
- Further data read-outs from expanded Phase 2a study expected Q4 2021
- Pivotal trial to commence in H2 2022, subject to Phase 2a data
Multiple industry-based collaborations in progress
Our progress to date
- Four additional collaboration agreements signed with major pharmaceutical/biotechnology companies and two with leading academic institutions exploring multiple methods of loading exosomes.
- Positive early pre-clinical data have shown efficient loading of nucleic acid payloads in its exosomes and these exosome candidates have also demonstrated functional payload delivery.
- Exosome pre-clinicalproof-of- concept data from current research collaborations are expected during Q4 2021.
Future milestones and high value opportunities
- Additional proof of concept data from current research collaborations expected in 2021
Potential to expand our therapeutical portfolio
Our progress to date
- New immortalised, licensable cell lines have been generated from the Company's iPSC platform as potential therapeutic agents for cancer immunotherapy and type 1 diabetes.
Future milestones and high value opportunities
- Validation of technology and publication of pre-clinicalproof-of- concept data
02 ReNeuron Annual Report for the year ended 31 March 2021
Introduction
Business development
Reconfiguration of our Non-Executive Board membership
During the period, we reduced the Non-Executive membership of the Board. As part of this reconfiguraton, Dr Tim Corn, an existing Non-Executive Director of the Company, became Chairman of the Board and Mark Evans, the Chairman of Obotritia Capital KGaA ("Obotritia"), was appointed as a non-independentNon-Executive Director of the Company.
Since the year-end, the Board has been strengthened further by the appointment of Iain Ross as Non-Executive Chairman and Barbara Staehelin as Senior Independent Non-Executive Director.
Placing, subscription and open offer outcome
Successful fundraise in December 2020, raising approximately £17.5 million (before expenses) which will allow the Group, inter alia, to deliver extended clinical data from its ongoing retinitis pigmentosa (RP) Phase 2a study and to deliver proof-of-conceptpre-clinical data from ongoing exosome collaborations which could enable potential out-licensing deals.
CTX stem cell therapy candidate
Strategic decision in June 2020 to progress stroke disability programme through regional partnerships. Fosun Pharma to develop and commercialise CTX programme in China under the exclusive out-licence agreement signed in April 2019.
Future developments
CTX cell therapy candidate is available for licensing in stroke disability outside China and in all territories in other potential indications.
We aim to reach important, data-driven potential value inflection points over the next 12 months which will enable us to pursue opportunities for securing potential out-licensing deals across all therapies.
Cash, cash
equivalents and
bank deposits
£22.2m
(2020: £12.6m)
ReNeuron Annual Report for the year ended 31 March 2021 03
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Disclaimer
ReNeuron Group plc published this content on 11 August 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 16 August 2021 12:32:06 UTC.