ReNeuron Group — Short delay to hRP trial, data now likely in Q421

ReNeuron Group (AIM: RENE)

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Research: Healthcare

ReNeuron Group — Short delay to hRP trial, data now likely in Q421

There has been a safety halt to the lead human retinal progenitor cell (hRPC) project. The issue was an eye infection in one patient following a successful surgical implantation of the hRPC. The cause is under investigation. If, as we assume, the trial restarts in the next few months, data should be available by Q421, a delay of perhaps three months. This is not significant within the overall developmental pathway and good data are needed to secure any future partnership from mid-2022. The valuation remains at £190m with cash estimated at £16m as of 31 March 2021.

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Healthcare

ReNeuron Group

Short delay to hRP trial, data now likely in Q421

Clinical update

Pharma & biotech

18 June 2021

Price

117.5p

Market cap

£67m

$1.32/£

Gross cash (£m) at 30 September 2020

(before placing of £17.5m in late 2020)

9.8

Shares in issue

56.85m

Free float

99.7%

Code

RENE

Primary exchange

LSE

Secondary exchange

N/A

Share price performance

%

1m

3m

12m

Abs

(7.8)

8.8

(13.2)

Rel (local)

(9.4)

3.0

(26.1)

52-week high/low

148.5p

72.5p

Business description

ReNeuron Group is a UK biotech company developing allogeneic cell therapies. Human retinal progenitor cells are the lead Phase I/IIa project for retinitis pigmentosa. There is a strong preclinical technology base in exosomes.

Next events

FY21 results (to March) and update

July 2021

Continuation Phase II data

Q421

hRPC pivotal study start

H222

Analyst

Dr John Savin

+44 (0)20 3077 2500

ReNeuron Group is a research client of Edison Investment Research Limited

There has been a safety halt to the lead human retinal progenitor cell (hRPC) project. The issue was a presumed eye infection in one patient following a successful surgical implantation of the hRPC. The cause is under investigation. If, as we assume, the trial restarts in the next few months, data should be available by Q421, a delay of up to three months. This is not significant within the developmental pathway and good data are needed to secure any future partnership from mid-2022. The valuation remains at £190m with cash estimated at £16m as of 31 March 2021.

Year end

Revenue (£m)

PBT*
(£m)

EPS*
(p)

DPS
(p)

P/E
(x)

Yield
(%)

03/19

2.7

(17.2)

(45.34)

0.0

N/A

N/A

03/20

6.2

(13.9)

(35.85)

0.0

N/A

N/A

03/21e

0.2

(14.4)

(32.85)

0.0

N/A

N/A

03/22e

0.2

(13.3)

(20.55)

0.0

N/A

N/A

Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.

hRPC is the major value driver with deal prospects

Retinitis pigmentosa (RP) is an inherited, degenerative eye disease caused by one of more than 100 different gene mutations. ReNeuron’s hRPC product might treat multiple genetic conditions so having a larger potential market than any one gene therapy. BioGen’s gene therapy recently failed a key study showing that gene modification is far from simple. The current continuation Phase IIa cohort receives two blebs of one million cells each on either side of the central vision area. This is to avoid the vison impairment seen in two patients in the first, single bleb 10-patient cohort and enables the dose to be doubled. Data from the first cohort indicate a sustained response in the eight successfully treated patients.

Infection causes short delay to Phase IIa trial

The protocol in nine patients is being tested in four centres: two in the United States, one in the UK and one in Spain. ReNeuron has had a recent setback as the most recently treated patient in the Phase IIa cohort suffered a presumed bacterial infection (endophthalmitis) after a successful hRPC implantation. As the eye cannot be sterilised (like skin), infection from bacteria naturally on the patient’s eye is an infection risk. There are low levels of endophthalmitis in procedures like cataract operations, up to 0.7%. Even simple injections, as of Eylea or Lucentis, carry a small risk (0.03%). As injection of two precisely placed blebs under the retina is a novel procedure, this might have generated an increased procedural risk as most centres are new to the protocol. It is routine to halt trials if a safety signal emerges to investigate. If, as we assume, the trial resumes shortly, data are now likely in Q421 instead of Q3 as originally envisaged.

Valuation: Maintained at £190m

We continue to believe that ReNeuron should be in a good position to start a pivotal study in H222 and to look at a possible partnering in a high-value deal, depending on the Phase IIa data now potentially due in Q421. ReNeuron announced new major pharmaceutical and leading academic partners in exosome preclinical projects in March. Our indicative value is unchanged at £190m as at present it appears that the Phase IIa trial delay is not significant.

Exhibit 1: Financial summary

£'000s

2019

2020

2021e

2022e

Year end 31 March

IFRS

IFRS

IFRS

IFRS

PROFIT & LOSS

Revenue

 

 

2,720

6,165

238

182

Cost of Sales

0

0

0

0

Gross Profit

2,720

6,165

238

182

R&D expenses

(16,246)

(16,335)

(10,618)

(10,500)

SG&A expenses

(4,773)

(4,239)

(3,836)

(3,028)

EBITDA

 

 

(18,129)

(13,997)

(13,811)

(12,941)

Operating Profit (before amort. and except.)

 

(18,299)

(14,409)

(14,216)

(13,346)

Intangible Amortisation

0

0

0

0

Exceptionals

0

0

0

0

Operating Profit

(18,299)

(14,409)

(14,216)

(13,346)

Other

0

0

0

0

Net Interest

1,064

551

(211)

64

Profit Before Tax (norm)

 

 

(17,235)

(13,858)

(14,427)

(13,282)

Profit Before Tax (FRS 3)

 

 

(17,235)

(13,858)

(14,427)

(13,282)

Tax

2,887

2,446

1,600

1,600

Profit After Tax (norm)

(14,348)

(11,412)

(12,827)

(11,682)

Profit After Tax (FRS 3)

(14,348)

(11,412)

(12,827)

(11,682)

Average Number of Shares Outstanding (m)

31.6

31.8

39.0

56.8

EPS - normalised (p)

 

 

(45.34)

(35.85)

(32.85)

(20.55)

EPS - FRS 3 (p)

 

 

(45.34)

(35.85)

(32.85)

(20.55)

Dividend per share (p)

0.0

0.0

0.0

0.0

BALANCE SHEET

Fixed Assets

 

 

1,522

1,229

1,104

979

Intangible Assets

186

186

186

186

Tangible Assets

632

452

452

452

Other

704

591

466

341

Current Assets

 

 

29,988

19,147

21,374

9,853

Stocks

0

0

0

0

Debtors

834

696

696

696

Cash and deposits

26,386

12,625

16,178

4,657

Other

2,768

5,826

4,500

4,500

Current Liabilities

 

 

(7,402)

(6,446)

(4,446)

(4,446)

Creditors

(7,261)

(6,280)

(4,280)

(4,280)

Short term borrowings

0

0

0

0

Short term leases

(141)

(166)

(166)

(166)

Other

0

0

0

0

Long Term Liabilities

 

 

(864)

(707)

(541)

(375)

Long term borrowings

0

0

0

0

Long term leases

0

0

0

0

Other long-term liabilities

(864)

(707)

(541)

(375)

Net Assets

 

 

23,244

13,223

17,491

6,011

CASH FLOW

Operating Cash Flow

 

 

(15,037)

(13,651)

(15,328)

(12,941)

Net Interest

303

258

14

64

Tax

3,129

(611)

2,923

1,600

Capex

(239)

(119)

(100)

(100)

Acquisitions/disposals

0

0

0

0

Financing

0

188

17,500

0

Dividends

0

0

0

0

Other

4,365

6,128

(1,457)

(144)

Net Cash Flow

(7,479)

(7,807)

3,553

(11,521)

Opening net debt/(cash)

 

 

(27,911)

(26,245)

(12,459)

(16,012)

HP finance leases initiated

0

0

0

0

Other

5,813

(5,979)

0

0

Closing net debt/(cash)

 

 

(26,245)

(12,459)

(16,012)

(4,491)

Source: ReNeuron accounts, Edison Investment Research

General disclaimer and copyright

This report has been commissioned by ReNeuron Group and prepared and issued by Edison, in consideration of a fee payable by ReNeuron Group. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for ‘wholesale clients’ within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are ‘wholesale clients’ for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a ‘personalised service’ and, to the extent that it contains any financial advice, is intended only as a ‘class service’ provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the ‘FPO’) (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the ‘publishers' exclusion’ from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

General disclaimer and copyright

This report has been commissioned by ReNeuron Group and prepared and issued by Edison, in consideration of a fee payable by ReNeuron Group. Edison Investment Research standard fees are £49,500 pa for the production and broad dissemination of a detailed note (Outlook) following by regular (typically quarterly) update notes. Fees are paid upfront in cash without recourse. Edison may seek additional fees for the provision of roadshows and related IR services for the client but does not get remunerated for any investment banking services. We never take payment in stock, options or warrants for any of our services.

Accuracy of content: All information used in the publication of this report has been compiled from publicly available sources that are believed to be reliable, however we do not guarantee the accuracy or completeness of this report and have not sought for this information to be independently verified. Opinions contained in this report represent those of the research department of Edison at the time of publication. Forward-looking information or statements in this report contain information that is based on assumptions, forecasts of future results, estimates of amounts not yet determinable, and therefore involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of their subject matter to be materially different from current expectations.

Exclusion of Liability: To the fullest extent allowed by law, Edison shall not be liable for any direct, indirect or consequential losses, loss of profits, damages, costs or expenses incurred or suffered by you arising out or in connection with the access to, use of or reliance on any information contained on this note.

No personalised advice: The information that we provide should not be construed in any manner whatsoever as, personalised advice. Also, the information provided by us should not be construed by any subscriber or prospective subscriber as Edison’s solicitation to effect, or attempt to effect, any transaction in a security. The securities described in the report may not be eligible for sale in all jurisdictions or to certain categories of investors.

Investment in securities mentioned: Edison has a restrictive policy relating to personal dealing and conflicts of interest. Edison Group does not conduct any investment business and, accordingly, does not itself hold any positions in the securities mentioned in this report. However, the respective directors, officers, employees and contractors of Edison may have a position in any or related securities mentioned in this report, subject to Edison's policies on personal dealing and conflicts of interest.

Copyright: Copyright 2021 Edison Investment Research Limited (Edison).

Australia

Edison Investment Research Pty Ltd (Edison AU) is the Australian subsidiary of Edison. Edison AU is a Corporate Authorised Representative (1252501) of Crown Wealth Group Pty Ltd who holds an Australian Financial Services Licence (Number: 494274). This research is issued in Australia by Edison AU and any access to it, is intended only for ‘wholesale clients’ within the meaning of the Corporations Act 2001 of Australia. Any advice given by Edison AU is general advice only and does not take into account your personal circumstances, needs or objectives. You should, before acting on this advice, consider the appropriateness of the advice, having regard to your objectives, financial situation and needs. If our advice relates to the acquisition, or possible acquisition, of a particular financial product you should read any relevant Product Disclosure Statement or like instrument.

New Zealand

The research in this document is intended for New Zealand resident professional financial advisers or brokers (for use in their roles as financial advisers or brokers) and habitual investors who are ‘wholesale clients’ for the purpose of the Financial Advisers Act 2008 (FAA) (as described in sections 5(c) (1)(a), (b) and (c) of the FAA). This is not a solicitation or inducement to buy, sell, subscribe, or underwrite any securities mentioned or in the topic of this document. For the purpose of the FAA, the content of this report is of a general nature, is intended as a source of general information only and is not intended to constitute a recommendation or opinion in relation to acquiring or disposing (including refraining from acquiring or disposing) of securities. The distribution of this document is not a ‘personalised service’ and, to the extent that it contains any financial advice, is intended only as a ‘class service’ provided by Edison within the meaning of the FAA (i.e. without taking into account the particular financial situation or goals of any person). As such, it should not be relied upon in making an investment decision.

United Kingdom

This document is prepared and provided by Edison for information purposes only and should not be construed as an offer or solicitation for investment in any securities mentioned or in the topic of this document. A marketing communication under FCA Rules, this document has not been prepared in accordance with the legal requirements designed to promote the independence of investment research and is not subject to any prohibition on dealing ahead of the dissemination of investment research.

This Communication is being distributed in the United Kingdom and is directed only at (i) persons having professional experience in matters relating to investments, i.e. investment professionals within the meaning of Article 19(5) of the Financial Services and Markets Act 2000 (Financial Promotion) Order 2005, as amended (the ‘FPO’) (ii) high net-worth companies, unincorporated associations or other bodies within the meaning of Article 49 of the FPO and (iii) persons to whom it is otherwise lawful to distribute it. The investment or investment activity to which this document relates is available only to such persons. It is not intended that this document be distributed or passed on, directly or indirectly, to any other class of persons and in any event and under no circumstances should persons of any other description rely on or act upon the contents of this document.

This Communication is being supplied to you solely for your information and may not be reproduced by, further distributed to or published in whole or in part by, any other person.

United States

Edison relies upon the ‘publishers' exclusion’ from the definition of investment adviser under Section 202(a)(11) of the Investment Advisers Act of 1940 and corresponding state securities laws. This report is a bona fide publication of general and regular circulation offering impersonal investment-related advice, not tailored to a specific investment portfolio or the needs of current and/or prospective subscribers. As such, Edison does not offer or provide personal advice and the research provided is for informational purposes only. No mention of a particular security in this report constitutes a recommendation to buy, sell or hold that or any security, or that any particular security, portfolio of securities, transaction or investment strategy is suitable for any specific person.

Frankfurt +49 (0)69 78 8076 960

Schumannstrasse 34b

60325 Frankfurt

Germany

London +44 (0)20 3077 5700

280 High Holborn

London, WC1V 7EE

United Kingdom

New York +1 646 653 7026

1185 Avenue of the Americas

3rd Floor, New York, NY 10036

United States of America

Sydney +61 (0)2 8249 8342

Level 4, Office 1205

95 Pitt Street, Sydney

NSW 2000, Australia

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