A leader in
stem cell and
exosome technologies
Interim Results for the six months ended
30 September 2021
Inside our report
Strategic Report
Operational highlights | 1 |
Overview | 2 |
Chairman's statement | 3 |
Operational review | 4 |
Financial review | 6 |
Interim Financial Statements | |
Unaudited Consolidated Statement | |
of Comprehensive Income | 8 |
Unaudited Consolidated Statement | |
of Financial Position | 9 |
Unaudited Consolidated Statement | |
of Changes in Equity | 10 |
Unaudited Consolidated Statement | |
of Cash Flows | 11 |
Notes to the Interim Financial | |
Statements | 12 |
Other information | |
Directors and Advisers | 16 |
Shareholder Information | IBC |
Welcome to our Interim Results for the six months ended
30 September 2021
ReNeuron is a UK-based Proprietary Stem Cell and Exosome Technologies company.
Our vision is to develop off-the- shelf treatments for disease with significant unmet needs.
Who ReNeuron is
ReNeuron is a UK-based proprietary stem cell and exosome technologies company harnessing its unique technologies to develop 'off-the-shelf' treatments for disease with significant unmet needs.
ReNeuron's Products
ReNeuron's lead hRPC programme is in Phase 2a clinical development for the blindness-causing disease, retinitis pigmentosa.
ReNeuron's CTX programme is currently under evaluation in stroke disability with Fosun in China.
ReNeuron's Platforms
ReNeuron's lead exosome platform offers a delivery mechanism for a variety of payloads such as siRNA, mRNA, proteins, small molecules and genes.
ReNeuron's iPSC platform has a number of potential applications including investigation in their use to generate CAR-T and/or CAR-NK cells.
Operational highlights
hRPC stem cell therapy candidate
for retinal disease:
- In June, enrolment into the higher dose Phase 2a extension study was temporarily suspended due to a presumed case of bacterial interocular infection
- Following a completed investigation, and with Data and Safety Monitoring Board approval, by October the study was reopened in all geographies
- First subject, post lifting of the suspension, was treated in mid-October with early data from the extension study expected in late Q1 2022
Exosome platform:
- Seven collaborations now proceeding with global pharma, biotech and academic institutions, with more expected in the coming 12 months
- Pre-clinicaldata indicates that ReNeuron's Exosome drug delivery technology can effectively deliver therapeutic proteins to the brain to potentially treat neurological diseases
Introduction
Other operational updates:
- Collaboration signed with University College London (UCL) investigating the use of ReNeuron's induced pluripotent stem cell (iPSC) platform to potentially generate CAR-T and/or CAR-NK cells
- Positive data from a separate UCL collaboration demonstrating that ReNeuron's iPSCs can be differentiated into Schwann cells with potential applications such as peripheral nerve damage repair
Corporate and
Organisational Development:
- In July Iain Ross was appointed as Non-Executive Chairman with Dr Tim Corn stepping down but continuing to serve as Non-Executive Director. Additionally Barbara Staehelin joined the board as Senior Independent Non- Executive Director
- In May Dr Stefano Pluchino joined the executive team as Chief Scientific Officer
- Post period end in October 2021, Catherine Isted, ACMA, joined the Board, replacing Michael Hunt as Chief Financial Officer
- In October 2021, following nearly 9 years of service to the board, Professor Sir Chris Evans OBE stood down as a Non-Executive Director, remaining as an adviser to the Board
Find out more at
www.reneuron.com
Financial highlights
- Revenue for the period of £58,000 relating to royalty income (H1 2020: £41,000)
- Loss for the period of £5.2 million (H1 2020: loss of £7.1 million) driven by lower costs
- Reduced costs incurred in the period of £6.1 million (H1 2020: £7.9 million) primarily driven by lower R&D spend following cessation of the Company's stroke disability programme
- Increased net cash used in operating activities of £4.6 million (H1 2020: £2.6 million) with H1 2020 benefitting from a £2.9m R&D tax credit receipt
-
Cash, cash equivalents and bank deposits at
30 September 2021 of £17.4 million (31 March 2021: £22.2 million) providing at least a 12-month runway
ReNeuron Interim Results for the six months ended 30 September 2021 01
The temporary suspension of our retinitis pigmentosa programme was an unexpected challenge in the first half of 2021, but with recruitment now resumed we look forward to reporting results from the high dose extension part of this phase 2a trial. Meanwhile, exosomes are becoming an increasingly exciting method for delivering payloads into patients and we are therefore optimistic that we can increase the number of partnerships in this area while continuing to progress our current collaborations toward the clinic. We feel we are in the right place, at the right time, with the right technology to be a leader in exosomes and look forward to providing further updates on our progress as the excitement in this area continues to grow.
Olav Hellebø Chief Executive Officer
Overview
ReNeuron has seen encouraging results from all aspects of its operations with strong progress in its seven Exosome collaborations and the resumption of its retinitis pigmentosa extension study. The exosomes platform has generated significant pre-clinical data in delivery
of functional proteins to the brain while the retinitis pigmentosa extension study is expected to produce initial data by late Q1 2022.
In the period ReNeuron welcomed Iain Ross as the Company's new Chairman and also Barbara Staehelin joined the board as the Senior Independent Non- Executive Director. Additionally, in October, Catherine Isted joined ReNeuron as Chief Financial Officer. Financially ReNeuron ended the period with cash of £17.4 million, providing a cash runway of in excess of
12 months and the Company looks forward to the year ahead maximising and building on the foundations of the year to date.
02 ReNeuron Interim Results for the six months ended 30 September 2021
Strategic Report
Iain Ross
Chairman's statement
Having been appointed as the new Chairman in
July 2021, I am absolutely committed to working with an effective Board and management team to accelerate the development of this business and to create realisable value for all shareholders. I have been impressed by the quality of the science, the breadth of the Company's proprietary stem cell based technology platforms and the skills and competencies of our scientific team.
Our priority now is to focus on the immediate key growth drivers, including securing long-term industrial partnerships and investing in those assets with inherent and potential realisable value.
Retinitis pigmentosa has a devastating impact on patients' lives and we have been encouraged by the early stage Phase 2a clinical data generated to date. We recognise that the clinical data generated over the next few months will determine the most appropriate strategy to take this programme forward. In addition, our differentiated exosome technology platform presents us with a unique opportunity to compete in an exciting
and fast developing sector and as a result we intend to build on the momentum already generated through the partnerships we have established and those we intend to target over the coming months.
Despite the breadth of our stem cell based platforms, if we are to succeed, we need to be prepared to make tough decisions and only progress and invest in those programmes whereby true value can be created.
Accordingly, where necessary we will look to share the value creating potential of our assets to secure substantive third-party collaborations, thereby increasing significantly the probability of success in terms of product development and value creation. The Board and management team will continue to assess all opportunities to create value through organic growth but also, as appropriate, explore technology licensing and acquisition opportunities to accelerate and enhance the overall value proposition of our Company.
I look forward to continuing to work with the ReNeuron team and all our stakeholders.
Iain Ross
Non-Executive Chairman
30 November 2021
ReNeuron Interim Results for the six months ended 30 September 2021 03
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ReNeuron Group plc published this content on 07 December 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 07 December 2021 11:41:07 UTC.