ReNeuron Group plc

TICKER: RENE     EXCHANGE: AIM

ReNeuron Group plc is an AIM listed biotechnology company developing allogeneic cell therapies. Its first product is the CTX neural stem cell therapy for the treatment of chronic stroke disability with results expected in early 2020. Its second product is human retinal progenitor cells (hRPCs) which are being studied for RP in a Phase I/IIa study.

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Encouragement from interims
Published: Dec 09 2019

ReNeuron Group plc is an AIM listed biotechnology company developing allogeneic cell therapies. Its first product is the CTX neural stem cell therapy for the treatment of chronic stroke disability with results expected in H1 2021. Its second product is human retinal progenitor cells (hRPCs) which are being studied for RP in a Phase I/IIa study. 
The Group ended H1’20 with a cash balance of £21.3m (£26.4m at YE’19). Bearing in mind its two ongoing clinical programs, this is efficient budgeting. The announcement that both clinical programs are now being expanded, suggests that some cost acceleration in H2’20 is to be expected. ReNeuron’s net loss in H1’20 was £3.9m (£5.4m in H1’19) with R&D expenses of £9.2m, which increased from £7.5m in H1’19, rightly comprising the majority of the £11.8m total operational spend (£10.1m in H1’19).
Last week ReNeuron noted in the H1’19 announcement that their focus was being shared between the CTX neural stem cell product for chronic stroke in a pivotal Phase II study, and the Phase I/IIa study of their human retinal progenitor cell (hRPC) product for RP. With the startling, but early, data in RP patients, first announced in early 2019, and the deferral of the results in the CTX product until H1’21, the former second product in ReNeuron’s pipeline has been promoted to premier position in terms of investor attention, clinical trial results announcements and partnering potential.
After a year dominated by early positive clinical trial results for the hRPC product and an associated YTD 180% share price increase, investors may have forgotten that 2019 also saw the broad partnership signed with Fosun Pharma. That deal encompasses both hRPC and CTX products for the Chinese market worth up to £80m in upfront, and milestone payments plus attractive double-digit percentage royalties. 
The H1’20 financial results brought the year to a positive close. A strong cash position enables the expansion of both of its clinical programs and notably the scale of the hRPC program has been expanded in order to accelerate the product’s regulatory approval. Further clinical data on the hRPC program is expected in 2020 before the first pivotal study on the CTX program in chronic stroke reads-out in H1’21.
 
Now the dust has settled
Published: Nov 19 2019

ReNeuron Group is an AIM listed biotechnology company developing allogeneic cell therapies. Their clinical data presentation at last month’s American Academy of Ophthalmology (AAO) meeting was met with some stock price weakness, whereas updates reported in February saw startling vision gains reported. 
The first 12 patients in the Phase I study portion will now be followed for safety only. Two recently-dosed patients experienced some procedure-related vision loss. Overall, the results to date remain encouraging, while reminding us how early on the learning curve this technology is.
ReNeuron’s February announcement of the results of the first, three-patient cohort in its Phase I/IIa clinical study of the human retinal progenitor cell (hRPC) therapy for retinitis pigmentosa (RP) showed rapid and significant visual acuity gains. In March, it announced that the review of this data by the drug safety monitoring board had enabled in the next three-patient cohort in the Phase II part of the study to be dosed, and next in September the dosing of the final cohort was reported to be underway. 
The second cohort comprised patients with a greater baseline visual acuity (i.e. less severe, or have better vision at baseline). The data on three of these less severe RP patients at the 90-day time point showed lower visual acuity gains than the first three patients dosed and in addition, two other new patients experienced some procedure-related vision loss.
With results on only 8 of 22 patients presented so far, the data from this study needs to mature further. Longer-term (180-days of follow-up) read-outs in the first 3 (most severe) patients dosed continue to be encouraging.

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