ReNeuron Group plc Annual Report and Accounts 2021

Developing stem cell technologies to improve patients’ lives

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Our vision is to improve patients’ lives through our proprietary stem cell technologies.

As a leader in cell-based therapeutics, we develop allogeneic stem cell technology platforms, stem cell derived exosomes and induced pluripotent stem cells (iPSCs).

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.

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.

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.

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.

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.

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.

Group at a glance

Our lead clinical programme

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hRPC for retinal diseases

Our hRPC stem cell therapy could change the lives of patients suffering from retinitis pigmentosa (RP) and also has potential utility in other eye diseases.

Our pre-clinical platforms

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Exosome nanomedicine platform

Our exosomes could change the lives of patients where current treatment options are limited.

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iPSCs platform

Our iPSCs could expand our therapeutic portfolio, targeting a broad range of diseases

Our performance

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Chairman's Statement

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Chief Executive Officer’s review of performance

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.

Dr. Tim Corn

Chairman

Having received regulatory approvals in the UK and in Spain, the Company now has three clinical sites in the US, one in the UK and one in Spain.

Olav Hellebø

Chief Executive Officer

photo of the chair

Chairman's statement

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.

Dr. Tim Corn

Chairman

photo of the chair

Chief Executive Officer’s review of performance

Having received regulatory approvals in the UK and in Spain, the Company now has three clinical sites in the US, one in the UK and one in Spain.

Olav Hellebø

Chief Executive Officer

Our marketplace

Meeting market needs through our therapeutic candidates

Our progress

A year of progress toward changing patient's lives

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hRPC for retinal diseases

26 patients have been treated in the Phase 1/2a study including 4 in the expanded Phase 2a.

New clinical sites opened with sites in the US, EU and UK.

Subjects followed out to 12 months show a clear efficacy signal with a favourable risk/benefit profile.

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Exosome nanomedicine platform

Our focus has been on the potential of our exosomes as a drug delivery vehicle.

7 ongoing research collaboration projects ongoing with both commercial and academic partners.

Our medium-term goal is to deliver in-vivo proof of concept data.

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iPSC platform

Our iPSCs can develop into new conditionally immortalised cell lines as potential therapeutic agents for subsequent licensing to third parties.

New conditionally immortalised cell lines generated from our iPSC platform as potential therapeutic agents for cancer immunotherapy and type 1 diabetes.

Research collaborations under negotiation and ongoing to validate the technology and publish pre-clinical proof of concept data.

Our competitive advantages

We are positioned for success . . .

  • Our patent estate consists of over 40 patents worldwide covering our cell-based therapies, exosome and iPSCs technologies.
  • Our hRPC programme is an allogeneic cell-based therapeutic approach to retinal disease. An efficient, patented process is used to produce hRPCs.
  • Our high-yielding human neural stem cell derived exosomes have proven ability to be loaded with siRNA, miRNA and proteins, and are able to cross the blood brain barrier.
  • Our CTX derived IPSC technology allows us to create new cell based therapeutic candidates as well as derive exosomes with the capability to target specific tissues.
  • Our CTX drug product is a proprietary allogeneic cell therapy produced by our well-established, scalable manufacturing process.
  • Our hRPCs and CTX cells can be cryopreserved, which provides flexibility in terms of scheduling patient treatment.
  • This makes our product similar to conventional ‘off-the-shelf’ pharmaceuticals/biologics.
  • Our cryopreservation process allows us to develop the therapies and transport them globally.
  • Our therapy development pipeline spans the pre-clinical and clinical development process.
  • The ongoing Phase 2a study in retinitis pigmentosa has been expanded to allow for subsequent potential single pivotal clinical study and shorter route to market.
  • The exosomes we are harnessing for use are a by-product of our CTX cells. They can be produced at an industrial scale without affecting the quality and consistency of the final product. They have potential as both a drug load/delivery vehicle and as a therapeutic.
  • Our iPSC platform has potential for new allogeneic cell therapeutics producible and purifiable at scale, and for exosomes based on non neural cell types.