ReNeuron: Interim Results For The Six Months Ended 30 September 2009
Operational Highlights:
• ReN001 stem cell therapy for stroke:
o Favourable ethical opinion, subject to conditions, given by UK ethics body for Phase I clinical trial, following earlier UK regulatory approval
o Supplemental data package subsequently generated to meet remaining ethical approval condition
o Five peer-reviewed papers published in the period regarding safety, efficacy, mechanism of action and manufacture of lead CTX stem cell line used in ReN001 programme
• Positive pre-clinical efficacy data presented with ReN009 stem cell therapy for peripheral arterial disease – initial clinical trial targeted to commence in 2011 using CTX stem cell line
• Long shelf-life, frozen formulation of CTX cell product developed, for subsequent clinical application in ReN001 and ReN009 programmes
• Three further peer-reviewed papers published in the period regarding positive pre-clinical data with ReN003 cell line for retinal diseases and research with ReNcell® product for non-therapeutic applications
• ReNeuron’s Guildford facility granted full therapeutic application licence by UK Human Tissue Authority, following audit
Financial Highlights
• Share placing to raise £3.0 million, before expenses, completed in the period, together with capitalisation of outstanding £2.5 million convertible loan notes and accrued interest
• Further £5.0 million equity finance facility secured from the Company’s joint broker, Matrix Corporate Capital LLP, post-period end, meeting funding requirements through to mid-2011, assuming facility is fully utilised
• Loss for the period reduced by 39% to £1.9 million (2008: £3.1 million); net cash outflow from operating activities reduced by 50% to £1.5 million (2008: £3.0 million); cash and cash equivalents at 30 September 2009 of £2.1 million (2008: £0.8 million).
Commenting on the results, Professor Trevor Jones, Chairman, said:
“During the six months to 30 September 2009, and subsequently, we have made significant progress across all areas of our operations. After a lengthy and exhaustive review process, our pioneering ReN001 therapy for stroke has received both UK regulatory and conditional ethical approvals for a first-in-man clinical study and we remain confident of meeting the remaining requirements to allow initiation of this clinical trial early in 2010.
“Our ReN009 therapy for peripheral arterial disease in diabetics is showing great promise pre-clinically, with an initial clinical trial targeted for 2011. Furthermore, we have developed a commercially attractive, second-generation formulation of our lead CTX cell line, our core therapeutic asset. We have a much reduced cost base reflected in the interim results for the period and we have also greatly enhanced the Group’s financial position by way of a £3 million equity placing during the period and a further £5 million equity draw-down facility secured subsequently. We look forward to a period of further substantial progress over the coming year.”
• ReN001 stem cell therapy for stroke:
o Favourable ethical opinion, subject to conditions, given by UK ethics body for Phase I clinical trial, following earlier UK regulatory approval
o Supplemental data package subsequently generated to meet remaining ethical approval condition
o Five peer-reviewed papers published in the period regarding safety, efficacy, mechanism of action and manufacture of lead CTX stem cell line used in ReN001 programme
• Positive pre-clinical efficacy data presented with ReN009 stem cell therapy for peripheral arterial disease – initial clinical trial targeted to commence in 2011 using CTX stem cell line
• Long shelf-life, frozen formulation of CTX cell product developed, for subsequent clinical application in ReN001 and ReN009 programmes
• Three further peer-reviewed papers published in the period regarding positive pre-clinical data with ReN003 cell line for retinal diseases and research with ReNcell® product for non-therapeutic applications
• ReNeuron’s Guildford facility granted full therapeutic application licence by UK Human Tissue Authority, following audit
Financial Highlights
• Share placing to raise £3.0 million, before expenses, completed in the period, together with capitalisation of outstanding £2.5 million convertible loan notes and accrued interest
• Further £5.0 million equity finance facility secured from the Company’s joint broker, Matrix Corporate Capital LLP, post-period end, meeting funding requirements through to mid-2011, assuming facility is fully utilised
• Loss for the period reduced by 39% to £1.9 million (2008: £3.1 million); net cash outflow from operating activities reduced by 50% to £1.5 million (2008: £3.0 million); cash and cash equivalents at 30 September 2009 of £2.1 million (2008: £0.8 million).
Commenting on the results, Professor Trevor Jones, Chairman, said:
“During the six months to 30 September 2009, and subsequently, we have made significant progress across all areas of our operations. After a lengthy and exhaustive review process, our pioneering ReN001 therapy for stroke has received both UK regulatory and conditional ethical approvals for a first-in-man clinical study and we remain confident of meeting the remaining requirements to allow initiation of this clinical trial early in 2010.
“Our ReN009 therapy for peripheral arterial disease in diabetics is showing great promise pre-clinically, with an initial clinical trial targeted for 2011. Furthermore, we have developed a commercially attractive, second-generation formulation of our lead CTX cell line, our core therapeutic asset. We have a much reduced cost base reflected in the interim results for the period and we have also greatly enhanced the Group’s financial position by way of a £3 million equity placing during the period and a further £5 million equity draw-down facility secured subsequently. We look forward to a period of further substantial progress over the coming year.”