Last close As at 05/08/2026
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▲ −0.02 (−0.81%)
Market capitalisation
EUR248m
Research: Healthcare
For the third consecutive time, Oryzon Genomics has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation. This external recognition highlights Oryzon’s key R&D activities, including its lead central nervous system (CNS) asset, vafidemstat, and lead oncology asset, iadademstat, and overall contributions to the field of epigenetics. Along with the acknowledgement, the INNOVATIVE SME Seal may allow Oryzon to benefit from certain tax deductions and incentives, as well as potential access to certain financing facilities.
Written by
Oryzon Genomics |
Third time is a charm; INNOVATIVE SME Seal |
External recognition |
Pharma and biotech |
5 April 2024 |
Share price performance
Business description
Analysts
Oryzon Genomics is a research client of Edison Investment Research Limited |
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For the third consecutive time, Oryzon Genomics has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation. This external recognition highlights Oryzon’s key R&D activities, including its lead central nervous system (CNS) asset, vafidemstat, and lead oncology asset, iadademstat, and overall contributions to the field of epigenetics. Along with the acknowledgement, the INNOVATIVE SME Seal may allow Oryzon to benefit from certain tax deductions and incentives, as well as potential access to certain financing facilities.
Year |
Revenue (€m) |
PBT* |
EPS* |
DPS |
P/E |
Yield |
12/22 |
15.7 |
(6.3) |
(0.07) |
0.0 |
N/A |
N/A |
12/23 |
14.2 |
(6.0) |
(0.06) |
0.0 |
N/A |
N/A |
12/24e |
12.9 |
(4.2) |
(0.03) |
0.0 |
N/A |
N/A |
12/25e |
33.7 |
15.5 |
0.29 |
0.0 |
7.0 |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
As per the announcement, Oryzon has received the INNOVATIVE SME Seal from the Spanish Ministry of Science and Innovation, and will accordingly be registered in the Public Registry of Innovative SMEs. We view this as an encouraging announcement for the company, marking formal acknowledgement of its efforts to advance novel therapies with epigenetic targets. Oryzon’s two clinical-stage assets both target LSD1, a histone-modifying enzyme that forms part of complexes responsible for the regulation of genes implicated in both cancer and CNS indications.
In CNS, vafidemstat has been tested in over 400 subjects, and has shown desirable safety and tolerability. The lead programme is targeting borderline personality disorder (BPD), for which the Phase IIb PORTICO trial concluded in January 2024. While the study did not meet its primary endpoints, vafidemstat was favoured over placebo in all measures, and Oryzon plans to request an End of Phase II (EoP2) meeting with the FDA in Q224 to discuss a potential registrational Phase III programme. Beyond BPD, vafidemstat is also in a Phase IIb trial (EVOLUTION) for schizophrenia, a timeline update for which is expected in 2024. It is also being explored as a potential treatment for Kabuki syndrome, a rare congenital disorder caused by variants in the KMT2D gene. Management believes LSD1 inhibition represents a promising treatment approach and plans to submit an IND application in 2024.
In oncology, the lead programme (FRIDA) is evaluating iadademstat in combination with gilteritinib in patients with relapsed/refractory AML harbouring the FLT3 mutation. Oryzon is targeting the second-line AML treatment setting, which could expedite the route to market compared to other drugs in development targeting the first-line setting, in our view. The first cohort for FRIDA (six patients) has completed treatment, showing that the combination is safe with anti-leukemic activity; further interim results from FRIDA are expected in Q224. Iadademstat is also being developed as a potential treatment for small-cell lung cancer and high-grade extrapulmonary neuroendocrine tumours. For a more detailed overview of Oryzon’s active clinical pipeline, we direct readers to our previous update note.
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Research: Healthcare
Mendus has reported gross proceeds of c SEK69.1m from the exercise of series TO3 warrants that were issued in connection with the July 2023 raise of SEK317m. Management anticipates that these proceeds will extend the cash runway to Q325 and will be applied to progress its clinical pipeline, mainly in preparation for a registrational trial for lead cancer vaccine vididencel, targeting acute myeloid leukaemia (AML) in the maintenance setting. Management expects the registrational study to commence in H225. In light of the challenging macroenvironment, we view this raise as a positive development for Mendus as it should also support operations as the company progresses through the AMLM22-CADENCE trial, which is anticipated to start patient recruitment this month.