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Currency in CHF
Last close As at 08/06/2023
CHF4.25
▲ 0.17 (4.17%)
Market capitalisation
CHF76m
Research: Healthcare
Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatment resistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in June 2022. Newron intends to begin a potentially pivotal multinational Phase III study (study 003) in TRS patients (expected to start in H223) and, in our view, its initiation represents a future catalyst for investor attention. We anticipate that the 52-week results from the full evenamide extension study (study 015) in Q124, if positive, will further enhance the existing evenamide data package and support future regulatory discussions.
Newron Pharmaceuticals |
Positive top-line data to support clinical progress |
Clinical trial update |
Pharma and biotech |
20 March 2023 |
Share price performance
Business description
Analysts
Newron Pharmaceuticals is a research client of Edison Investment Research Limited |
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Newron Pharmaceuticals has announced positive top-line results from its Phase II trial (study 014) assessing evenamide, a glutamate modulator, as an add-on therapy to antipsychotics in moderate-to-severe treatmentresistant schizophrenia (TRS). While detailed data (for the full 161 patient cohort over the six-week treatment period) have not been disclosed, management asserts that the results were similar to the six-week interim safety and efficacy data from the first 100 patients reported in June 2022. Newron intends to begin a potentially pivotal multinational Phase III study (study 003) in TRS patients (expected to start in H223) and, in our view, its initiation represents a future catalyst for investor attention. We anticipate that the 52-week results from the full evenamide extension study (study 015) in Q124, if positive, will further enhance the existing evenamide data package and support future regulatory discussions.
Year end |
Revenue (€m) |
PBT* (€m) |
EPS* |
DPS |
P/E |
Yield |
12/21 |
5.76 |
(14.12) |
(0.79) |
0.0 |
N/A |
N/A |
12/22 |
6.09 |
(16.99) |
(0.95) |
0.0 |
N/A |
N/A |
12/23e |
6.46 |
(17.11) |
(0.96) |
0.0 |
N/A |
N/A |
12/24e |
6.85 |
(22.27) |
(1.25) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
In June 2022, Newron announced encouraging interim results from the first 100 patients after the mandated six weeks of treatment in study 014. This group was primarily treated with the 7.5mg and 15mg bid dose and reported a 12% reduction in schizophrenic symptoms on the Positive and Negative Syndrome Scale (PANSS), which is considered the ‘gold standard’ for assessing antipsychotic treatment efficacy. Moreover, the Clinical Global Impressions (CGI) ratings showed a ‘responder’ rate of 77% and a Clinical Global Impression of Severity (CGI-S) improvement of 0.7. Patients who entered the extension study (study 015) continued to exhibit improvement in underlying symptoms, highlighting the incremental benefit from long-term treatment. In February 2023, Newron reported results from the first 100 randomised patients, of which 77 patients had completed the study after 52 weeks of treatment. The proportion of patients experiencing PANSS improvement was three times greater than that observed at week six, in addition to improvements in the Clinical Global Impression of Change (another 10% increase from 27% at week six) and CGI-S (doubled over the 10% figure at week six) scales.
As per the top-line results, of the 161 patients randomised, 153 (95%) completed the six-week treatment period and 144 (94%) advanced to the extension study (study 015). Management has said that top-line results (both safety and efficacy) were in line with those reported for the first 100 patients (at week six). Notably, similar efficacy was observed irrespective of the different dosage strengths (later cohorts were also administered the higher 30mg dose vs 7.5mg and 15mg primarily used for the initial participants). We anticipate that clinical benefit could continue to improve with treatment over a longer period (in line with the observed trend for the first 100 patients) and systematic differences between doses of evenamide, if observed, could become clearer with time. Newron now plans to commence a potentially pivotal Phase III randomised, placebo-controlled trial (study 003) for evenamide in patients with TRS in H223.
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Research: Financials
CoinShares International (CS) reported a moderate £6.5m EBITDA loss in FY22 (vs a £121.1m profit in FY21), affected by the ‘crypto winter’ (which follows the exuberance of 2021), marked by declining asset prices and high-profile bankruptcies. The turmoil last year (most notably the collapse of the FTX exchange) led CS to wind down its nascent B2C business and take a more cautious approach in its capital markets infrastructure (CSCM) division. Nevertheless, its balance sheet remains sound with total equity of £204.0m at end-2022 (vs £200.9m at end-2021).
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