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    RENE   GB00BF5G6K95

RENEURON GROUP PLC

(RENE)
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Delayed Quote. Delayed London Stock Exchange - 09/28 12:00:33 pm
90.909 GBX   -2.25%
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ReNeuron : Preliminary Results for the year ended 31 March 2021

07/08/2021 | 01:01pm EDT

8 July 2021

ReNeuron Group plc

("ReNeuron" or "the Company")

Preliminary Results for the year ended 31 March 2021

ReNeuron Group plc (AIM: RENE.L), a UK-based global leader in the development of cell-based therapeutics, announces its preliminary results for the year ended 31 March 2021.

Operational highlights

hRPC stem cell therapy candidate for retinal disease:

  • 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

Exosome and iPSC platforms:

  • 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
  • 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

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
    • CTX cell therapy candidate available for licensing in stroke disability outside China and in all territories in other potential indications

Board changes:

  • Non-executiveBoard membership reconfigured in September 2020 and CFO announced his retirement from the Board in March 2021
  • On 1 July 2021, Iain Ross appointed as Non-Executive Chairman
  • Recruitment of new Chief Financial Officer continues to progress well

Financial highlights

  • Successful fundraise in December 2020, raising approximately £17.5 million (before expenses)
  • Loss for the year slightly lower than expectations at £11.3 million (2020: loss of £11.4 million, including an upfront payment of £5.4 million, net of withholding tax, received through the licence agreement for
    ReNeuron's CTX and hRPC cell therapy programmes in Greater China with Fosun Pharma)
  • Reduced costs incurred in the period of £13.2 million (2020: £20.6 million)
  • Reduced cash used in operating activities of £6.1 million (2020: £14.3 million)
  • Cash, cash equivalents and bank deposits at 31 March 2021 of £22.2 million (2020: £12.6 million), providing at least a 12-month runway from the date of this announcement

Commenting on the results, Olav Hellebø, Chief Executive Officer, said:

"Over the previous financial year, we have been successful in designing and implementing an extension cohort in the phase 2a clinical trial of our hRPC cell therapy candidate in retinitis pigmentosa, including doubling of the dose and other changes designed to amplify the efficacy signal seen in earlier cohorts. We have received regulatory approvals in the US, UK and Spain, and have started enrolment in all countries. Although dosing was temporarily suspended during the investigation of a presumed bacterial infection, the clinical trial is being restarted, and we expect subjects to be treated shortly, with further data to be presented later in Q4 2021.

"Our exosome and iPSC platforms have also progressed well during the period, with multiple industry-based collaborations now in progress across both platforms and the prospect of pre-clinicalproof-of-concept data over the coming months.

"Our decision in 2020 to focus the Company's resources on our retinal disease programme and our exosome and iPSC platforms has resulted in significantly lower operating costs, as reflected in the results for the year. This renewed clarity of focus, together with the fundraise in December, will enable us to reach important, data-driven potential value inflection points across our programmes over the next 12 months."

Investor presentation:

Olav Hellebø, Chief Executive Officer; Rick Beckman, Chief Medical Officer; and John Hawkins, Financial Controller, will be hosting a live online presentation at 4.30pm today via the Investor Meet Company Platform. Investors can register for the meeting here: https://www.investormeetcompany.com/reneuron-group-plc/register-investor

A recording of the presentation will also available on the ReNeuron website in due course: www.reneuron.com.

ENQUIRIES:

ReNeuron

www.reneuron.com/investors

Olav Hellebø, Chief Executive Officer

Via Walbrook PR

Stifel Nicolaus Europe Limited (NOMAD and Joint Broker)

+44

(0)20 7710 7600

Ben Maddison, Stewart Wallace

Allenby Capital Limited (Joint Broker)

+44

(0)20 3328 5656

James Reeve/George Payne (Corporate Finance)

Tim Sohal (Sales & Corporate Broking)

Walbrook PR (Media & Investor Relations)

+44 (0)20 7933 8780 or reneuron@walbrookpr.com

Paul McManus/Alice Woodings

+44 (0)7980 541 893 / +44

(0)7407 804 654

This announcement contains inside information. The person responsible for arranging for the release of this

announcement on behalf of the Company is Olav Hellebø, Chief Executive Officer.

About ReNeuron

ReNeuron is a global leader in cell-based therapeutics, harnessing its unique stem cell technologies to develop 'off the shelf' stem cell treatments for disease with significant unmet needs. The Company's lead cell therapy candidate is in clinical development for the blindness-causing disease, retinitis pigmentosa.

ReNeuron is also advancing its proprietary exosome technology platform as a potential delivery system for drugs that treat diseases of the central nervous system and other disorders. The Company also has the ability through its conditionally immortalised induced pluripotent stem cell (iPSC) platform to make allogeneic tissue cells of choice; in-house programmes are currently focused on treatments for blood cancers and diabetes.

ReNeuron's shares are traded on the London AIM market under the symbol RENE.L. For further information visit www.reneuron.com

This announcement contains forward-looking statements with respect to the financial condition, results of operations and business achievements/performance of ReNeuron and certain of the plans and objectives of management of ReNeuron with respect thereto. These statements may generally, but not always, be identified by the use of words such as "should", "expects", "estimates", "believes" or similar expressions. This announcement also contains forward-looking statements attributed to certain third parties relating to their estimates regarding the growth of markets and demand for products. By their nature, forward-looking statements involve risk and uncertainty because they reflect ReNeuron's current expectations and assumptions as to future events and circumstances that may not prove accurate. A number of factors could cause ReNeuron's actual financial condition, results of operations and business achievements/performance to differ materially from the estimates made or implied in such forward-looking statements and, accordingly, reliance should not be placed on such statements.

CHAIRMAN'S STATEMENT

I am pleased to introduce the Group's Preliminary Results for the year ended 31 March 2021. It was a challenging year for everyone with the impact of the coronavirus pandemic and firstly, on behalf of the Company and the Board, I would like to thank our staff, our clinical trial subjects, our commercial and academic partners, our advisors and our shareholders for their continued commitment to the Company and for the resilience they have shown over the past 12 months.

Despite the challenges, the year has again been one of significant progress in both our clinical and strategic development, giving us continued encouragement regarding the potential of the Company's programmes in the short to medium term and beyond.

We remain highly encouraged by the positive one-year data from the initial cohorts of Phase 2a subjects treated in the ongoing Phase 1/2 clinical trial with our hRPC cell therapy candidate for retinitis pigmentosa. We were pleased to receive regulatory approval from the FDA, MHRA and the Spanish Regulatory Agency to expand the ongoing Phase 2a part of the study to treat patients with retinitis pigmentosa (RP) at a higher dose level, at clinical sites in the US, UK and Spain. We were disappointed that we recently had to suspend dosing of subjects across all sites after a subject unfortunately presented with a presumed case of bacterial endophthalmitis. 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. We look forward to reporting further Phase 2a data from the study in Q4 2021, rather than Q3 2021 as originally planned.

Our exosome technology is being exploited as a novel vector for delivering third party biological drugs and this partnering strategy reflects increasing industry interest in exosomes. We have signed a number of collaboration agreements with major pharmaceutical/biotechnology companies and academic institutions to explore the potential of the Company's exosomes to deliver novel therapeutic agents to the brain and other regions of the body. Early pre-clinical data have been positive and further data across the collaborations are expected in the coming months.

During the period, we have continued to progress our CTX cell-based iPSC technology in a number of potential applications. We are deploying this technology to develop new, immortalised allogeneic cell lines of varying types as potential therapeutic agents in diseases of unmet medical need for subsequent licensing to third parties.

During the year, we announced our intention to focus the Company's resources on our retinal disease programme and our exosome and iPSC research platforms. Consequently, we halted the PISCES III clinical trial of our CTX cell therapy candidate for stroke disability in the US and looked for opportunities to continue the programme through partnerships. We also announced our intention to license out the CTX cell therapy candidate in other indications.

During the COVID-19 pandemic, the safety of employees, suppliers, clinical trial participants and all other people with whom the Company interacts has been of over-riding importance to us. The Company has adapted throughout the year to continue to comply with governmental advice and requirements across its operations in the UK, EU and US, without significant impact on our priority internal research projects.

During the period, we reduced the non-executive membership of the Board of the Company. As part of this reconfiguration, I 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 in recognition of Obotritia's significant shareholding and ongoing support for the Company.

Since then, we have further configured the Board and I would like to welcome Iain Ross to the Board as Non- Executive Director and Chairman of the Board of Directors. Iain is a highly experienced board director with a career in the international life sciences and technology sectors that spans 40 years. He will be an excellent addition to the Board at a pivotal time for the Company and I wish him the best in his endeavours.

In March, Michael Hunt, CFO of ReNeuron resigned to pursue other projects. Michael joined ReNeuron in 2001 and with tenures over the years as both CFO and CEO of the Company, Michael has played a key role in the development of ReNeuron into the exciting business that it is today. I would like to thank Michael for his very significant contribution to the Company and wish him well in his future endeavours.

ReNeuron has a clear focus to deliver value-generating data across its programmes over the next twelve months and we look forward to updating our shareholders as we continue to make progress.

Dr Tim Corn

Outgoing Non-Executive Chairman and current Non-Executive Director

NEW CHAIRMAN'S STATEMENT

I am delighted to be joining ReNeuron at such a pivotal time as we look to ensure a significant uplift in shareholder value over the next few years.

I would like to thank Tim for his work over the last 10 months and will look forward to working alongside him as he continues his role as Non-Executive Director, as well as the rest of the Board and Management team.

Iain Ross

Newly Appointed Non-Executive Chairman, as of 1 July 2021

Disclaimer

ReNeuron Group plc published this content on 08 July 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 July 2021 16:23:58 UTC.


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Financials
Sales 2022 0,18 M 0,24 M 0,24 M
Net income 2022 - - -
Net cash 2022 9,53 M 12,9 M 12,9 M
P/E ratio 2022 -
Yield 2022 -
Capitalization 53,0 M 71,7 M 71,7 M
EV / Sales 2022 248x
EV / Sales 2023 85,3x
Nbr of Employees -
Free-Float 72,9%
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Managers and Directors
Olav Helleb° Chief Executive Officer & Executive Director
Iain Gladstone Ross Non-Executive Chairman
Richard L. Beckman Chief Medical Officer
Stefano Pluchino Chief Scientific Officer
Suzanne Hancock Head-Operations
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