Edison Investment Research - ReNeuron Group PLC (RQE1) Update: First patient treated in first US clinical study

Report

Edison Investment Research

Update: First patient treated in first US clinical study

ReNeuron has treated the first patient in its US Phase I/II clinical trial with its cell therapy candidate for the blindness-causing disease retinitis pigmentosa (RP). This is a significant step given we estimate peak sales of $445m for the programme, which could move straight into a pivotal Phase II/III study in H217, pending positive data in the Phase I/II by end-2016/early 2017. The next major valuation inflection point is now the Phase II stroke disability study data (with its CTX neural stem cells), due in mid-2016.

24/03/2016 5 EN

Underlying

ReNeuron Group PLC

See profile

GB00B0DZML60 United Kingdom

Provider

Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

See profile

Other Reports on these Companies

Edison Investment Research

ReNeuron Group - Biblical aspirations

ReNeuronâ€™s interim results for the six months to 30 September 2017 showcased a crucial juncture in the companyâ€™s history. With the first of two US placebo-controlled, late-stage studies in chronic stroke starting in 2018 and dosing ongoing in the US Phase I/II study in retinitis pigmentosa, ReNeuronâ€™s stem cell therapies are aimed at helping the disabled walk and the blind see. ReNeuron reported a loss of Â£9.6m for the six months (vs Â£7.7m in H117). In 2018 ReNeuronâ€™s profile will increase further as it conducts two clinical studies and opens an operational base in the US.

December 21, 2017 December 21, 2017 5 EN

Edison Investment Research

Milestones expected as pipeline progresses

The highlight of FY17 was positive Phase II efficacy data from ReNeuron’s PISCES II clinical trial. As this and its other clinical programmes in ophthalmology and its earlier stage exosome platform progress, ReNeuron is entering a period of potentially significant milestones over the next 12 to 18 months. We maintain our valuation of £291m, adjusting for FY17 cash and rolling the model forward, which is offset by moving out the clinical timeline for the Phase III pivotal trial in stroke, now expected to start in early 2018 (vs H217).

July 6, 2017 July 6, 2017 3 EN

Edison Investment Research

Global clinical pipeline strategy update

ReNeuron continues to prepare for its Phase III chronic stroke study (due to start in H217) and has indicated that it is making progress with the US/EU regulatory authorities. It intends to submit an IND in the US in Q217 and shortly after in the EU. ReNeuron also announced that it now plans to expand its ongoing Phase I/II retinitis pigmentosa (hRP cells) study to 20 patients in Phase II and commence a Phase II study in a new indication: cone-rod dystrophy (CRD). As a result, it will not continue development of CTX in critical limb ischaemia (CLI). We maintain our rNPV at £291m.

May 2, 2017 May 2, 2017 5 EN

Basilea Pharmaceutica - Cresemba milestone payments continue to roll in

Basilea Pharmaceutica has announced the triggering of a US$1.25m milestone payment from Pfizer, triggered by sustained strong sales of Cresemba in the Asia-Pacific region and China. This is the second FY24 milestone payment for the region and is incremental to the payment received in March. We note that, according to the latest available data, total in-market sales of Cresemba amounted to US$473m in the 12 months ending December 2023, representing a +26% year-on-year increase. Basilea is preparing to launch its Phase III programme for fosmanogepix, a broad-spectrum antifungal therapy, with the...

May 17, 2024 May 17, 2024 1 EN

Toby Thorrington

Toby Thorrington

AAC Clyde Space - Solid start to the year with further order growth

AAC Clyde Space offers exposure to the fast-growing low Earth orbit space market. A solid start to the year and continued order momentum are encouraging. We also note the internal restructuring to promote delivery of the group’s products and services. We expect this combination to drive an improving performance, albeit within the lumpy nature of the business, in turn improving investor confidence and the stock’s valuation.

May 17, 2024 May 17, 2024 1 EN

Richard Williamson

Richard Williamson

Tinexta - Typical seasonality in Q124

Tinexta’s Q124 results showed good progress in the two divisions that typically demonstrate more consistent (through the year) growth, Cyber Security and Digital Trust, which management expects to deliver higher growth over the next few years. Business Innovation demonstrated its typical seasonality and management therefore remains confident about the outlook for the year.

May 17, 2024 May 17, 2024 1 EN

Sign-up for free to access full reports immediately

Email Address*

Choose Password* ( 6 or more characters )

Due to regulatory restrictions regarding the distribution of financial research, this report is restricted to a specific region or investor type. Get access to exclusive reports by answering the questions below.

Select your country*

Get financial insights straight to your inbox

By clicking "register" you accept the Terms and Conditions & Privacy Policy

Already on ResearchPool?

Almost there...

Are you a professional investor?

Select your country

REGISTER

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

In order to access this report please create an account.

LOGIN

Update: First patient treated in first US clinical study

ReNeuron Group - Biblical aspirations

Milestones expected as pipeline progresses

Global clinical pipeline strategy update

Basilea Pharmaceutica - Cresemba milestone payments continue to roll in

AAC Clyde Space - Solid start to the year with further order growth

Tinexta - Typical seasonality in Q124

Create a free ResearchPool account to access full reports, get a personalised dashboard and follow providers or companies

Sign-up for free to access full reports immediately

ResearchPool Subscriptions

Get the most out of your insights

Why subscribe?

How to subscribe

ResearchPool Subscriptions

This report is only available to subscribers

Why subscribe?

How to subscribe