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Research: Healthcare
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.
Written by
ReNeuron Group |
Short delay to hRP trial, data now likely in Q421 |
Clinical update |
Pharma & biotech |
18 June 2021 |
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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* |
EPS* |
DPS |
P/E |
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
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Research: Metals & Mining
On 15 June, Lepidico announced that its one for seven entitlement (rights) offer to raise A$9.6m had closed ‘significantly oversubscribed’ to the extent that the company had taken advantage of the strength in demand to place a further 223.1m shares (plus options) with investors to raise an additional A$2.9m. The funds raised will be used to generate product samples for a new prospective customer, with which negotiations are well advanced. They will also be applied to fast-track initial development activities for the Phase 1 project in order to keep it on schedule for mining to start in Q3 CY22 and chemical plant commissioning in Q1 CY23 – thereby positioning Lepidico to take advantage of improving lithium market fundamentals – and also to start work on a full-scale 20,000tpa LCE Phase 2 plant.