“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 02/06/2023
EUR2.06
▲ 0.01 (0.49%)
Market capitalisation
EUR119m
Research: Healthcare
Oryzon Genomics has announced that it has enrolled the first patient into its collaborative Phase II trial investigating the use of its lead LSD1 inhibitor, iadademstat, in the treatment of relapsed and refractory (r/r) high-grade neuroendocrine carcinomas (NECs). The trial will be conducted in collaboration with the Fox Chase Cancer Center, a leading investigational cancer institute in the US, with Oryzon providing funding, iadademstat and technical advice. In our view, the first patient enrolment marks a significant clinical milestone for the study and begins iadademstat’s potential expansion into additional indications. We maintain our valuation of Oryzon at €847m or €15.5 per share. However, we will provide a further update in line with Oryzon’s full year results, which are expected in February 2023.
Oryzon Genomics |
First Phase II patient enrolled is clinical milestone |
Clinical update |
Pharma and biotech |
18 January 2023 |
Share price performance
Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||
Oryzon Genomics has announced that it has enrolled the first patient into its collaborative Phase II trial investigating the use of its lead LSD1 inhibitor, iadademstat, in the treatment of relapsed and refractory (r/r) high-grade neuroendocrine carcinomas (NECs). The trial will be conducted in collaboration with the Fox Chase Cancer Center, a leading investigational cancer institute in the US, with Oryzon providing funding, iadademstat and technical advice. In our view, the first patient enrolment marks a significant clinical milestone for the study and begins iadademstat’s potential expansion into additional indications. We maintain our valuation of Oryzon at €847m or €15.5 per share. However, we will provide a further update in line with Oryzon’s full year results, which are expected in February 2023.
Year end |
Revenue |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/20 |
9.5 |
(4.8) |
(0.07) |
0.0 |
N/A |
N/A |
12/21 |
10.6 |
(7.2) |
(0.09) |
0.0 |
N/A |
N/A |
12/22e |
14.4 |
(5.0) |
(0.05) |
0.0 |
N/A |
N/A |
12/23e |
15.9 |
(5.8) |
(0.06) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS is normalised, excluding amortisation of acquired intangibles, other income and exceptional items.
NECs are a rare form of cancer (US incidence is estimated at 12,000 new cases every year), which can form in various areas of the body, including the gastrointestinal tract (c 43% of cases), the lungs (c 30% of cases) and pancreas (c 7% of cases), meaning that symptoms can be varied, often leading to late diagnosis. While rare (c 5% of gastrointestinal NECs are high grade), high-grade (G3) NECs are extremely aggressive cancers with poor overall survival. Platinum-based chemotherapy is the established standard of care for advanced NECs; however, patients commonly relapse and there is currently no standard second-line treatment. Those who receive second-line treatment often exhibit extremely poor response rates, typically c 5–15%. We therefore believe the r/r setting represents a distinct opportunity for Oryzon and iadademstat in this indication.
As a reminder, Oryzon is investigating iadademstat in multiple oncology programmes, including the Phase I (FRIDA) study in r/r FLT3+ acute myeloid leukaemia and is preparing a Phase Ib/II (STELLAR) trial in metastatic small-cell lung cancer in combination with immune checkpoint inhibitors. Additionally, Oryzon recently reported encouraging results from its completed Phase IIa ALICE study in Acute Myeloid Leukaemia, in which iadademstat displayed an encouraging efficacy profile, achieving an objective response rate of 81% and median overall survival of 11.1 months.
|
|
Research: Healthcare
IRLAB Therapeutics has announced top-line data from its Phase IIb trial investigating mesdopetam as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). The drug did not meet the primary outcome of the study, change in daily hours of ‘ON time’ (the length of time a patient does not have symptoms) without troublesome dyskinesia compared to placebo with statistical significance. However, the results confirmed the safety and tolerability of mesdopetam and met the secondary efficacy endpoint in demonstrating significant anti-dyskinetic effects as measured by the Unified Dyskinesia Rating Scale (UDysRS), a clinically recognised scale for measuring dyskinesias. We believe the importance of the secondary endpoint should not be overlooked; FDA approval of Gocovri in PD-LID was based on two pivotal studies assessing changes in the UDysRS as the primary outcome, demonstrating its clinical relevance. IRLAB’s stock dropped c 60% following the news, which likely reflects market uncertainty over mesdopetam’s future clinical development. Based on this news, our valuation and estimates are under review.
Get access to the very latest content matched to your personal investment style.
