“Edison’s accessible and high-quality research gives us the opportunity to communicate an independent perspective of Tyman to a wide variety of potential stakeholders.”
Currency in EUR
Last close As at 24/03/2023
EUR0.68
▲ 0.03 (4.62%)
Market capitalisation
EUR34m
Research: Healthcare
Nicox’s Mont Blanc Phase III study of NCX-470 0.1% met the primary efficacy endpoint of demonstrating non-inferiority to latanoprost 0.005% for the reduction in intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Given the favourable safety profile also shown, these results bode well for the product’s likelihood of obtaining FDA approval, provided the second Phase III study, Denali, demonstrates similar efficacy parameters (results expected by Nicox after 2024). Mont Blanc did not meet the secondary endpoint of demonstrating statistical superiority to latanoprost, although NCX-470 showed statistically superior IOP reduction (p<0.049) at four of the six timepoints and numerically greater IOP reduction at all six timepoints. Altogether, the extent of NCX-470’s difference with latanoprost does not appear to be as substantial as what was shown in the earlier Dolomites Phase II study, which may restrain expectations surrounding the product’s differentiated positioning compared to the leading prostaglandin F2α analogue (PGA) drugs.
Nicox |
NCX-470 non-inferior to latanoprost in Mont Blanc |
Mont Blanc results |
Pharma and biotech |
31 October 2022 |
Share price performance
Business description
Analysts
Nicox is a research client of Edison Investment Research Limited. |
||||||||||||||||||||||||||||||||||||
Nicox’s Mont Blanc Phase III study of NCX-470 0.1% met the primary efficacy endpoint of demonstrating non-inferiority to latanoprost 0.005% for the reduction in intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension. Given the favourable safety profile also shown, these results bode well for the product’s likelihood of obtaining FDA approval, provided the second Phase III study, Denali, demonstrates similar efficacy parameters (results expected by Nicox after 2024). Mont Blanc did not meet the secondary endpoint of demonstrating statistical superiority to latanoprost, although NCX-470 showed statistically superior IOP reduction (p<0.049) at four of the six timepoints and numerically greater IOP reduction at all six timepoints. Altogether, the extent of NCX-470’s difference with latanoprost does not appear to be as substantial as what was shown in the earlier Dolomites Phase II study, which may restrain expectations surrounding the product’s differentiated positioning compared to the leading prostaglandin F2α analogue (PGA) drugs.
Year end |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
14.4 |
(10.2) |
(0.30) |
0.0 |
N/A |
N/A |
12/21 |
8.6 |
(15.5) |
(0.35) |
0.0 |
N/A |
N/A |
12/22e |
5.2 |
(17.3) |
(0.36) |
0.0 |
N/A |
N/A |
12/23e |
7.4 |
(16.4) |
(0.37) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
The IOP-lowering effect from baseline in the 691-patient study was 8.0–9.7mmHg for NCX-470 versus 7.1–9.4mmHg for latanoprost (reduction in time-matched IOP at 8am and 4pm across visits at week two, week six and month three). The difference in IOP reduction between NCX 470 and latanoprost was up to 1.0 mmHg in favour of NCX-470. The Dolomites trial showed that NCX-470 (at 0.065%) delivered up to 1.4mmHg increased IOP reduction versus latanoprost, meeting statistically superiority criteria. In our recent note, we estimated that a relative difference of at least c 1.5mmHg versus latanoprost in Mont Blanc would have enabled NCX-470 to solidly distinguish itself effectively against other glaucoma monotherapy drugs.
Nicox will examine subset analyses of the Mont Blanc study to better determine if certain patient profiles may achieve superior relative therapeutic effects, and it will continue to explore NCX-470’s ability to potentially provide retinal cell protection. However, we believe that the top-line results as reported in and of themselves do not appear to appreciably differentiate NCX-470’s IOP-lowering competitive profile as a monotherapy drug from latanoprostene bunod (Vyzulta) and bimatoprost.
Nicox reported that NCX-470 was well tolerated, with the most common adverse event being ocular hyperemia (11.9% of cases vs 3.3% of latanoprost patients), which is not surprising as NCX-470 (at 0.065%) also showed a c 10pp increase in the rate of ocular hyperemia versus the latanoprost arm in Dolomites. There were no ocular serious adverse events in Mont Blanc, and the NCX-470 study discontinuation rate (4.3%) was lower than that of the latanoprost arm (5.1%) .
|
|
Lithium Power International (LPI) announced on 28 October that its shareholders, as well as the shareholders of Bearing Lithium, approved Maricunga’s ownership consolidation, paving the way for the completion of the transaction in November. On 25 October the company provided a Q123 update that showed further gradual progress in the project’s development. Following the recent oversubscribed equity offering, LPI remains well capitalised. We maintain our valuation.
Get access to the very latest content matched to your personal investment style.
