Based in Sweden, IRLAB Therapeutics is focused on developing novel drugs for the treatment of neurodegenerative diseases utilising its ISP technology platform. Its two lead assets, mesdopetam and pirepemat, are in late-stage clinical trials for the symptomatic treatment of Parkinson’s disease (PD).
PD is characterised by a triad of cardinal motor symptoms, although non-motor symptoms are as debilitating and remain undertreated. Despite substantial efforts to develop disease-modifying approaches in PD, symptomatic treatment remains the mainstay.
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Update
Viktor Siewertz
CFO
Forecast net cash (SEKm)
74.2
Forecast gearing ratio (%)
N/A
% | 1M | 3M | 12M |
---|---|---|---|
Actual | 13.6 | 161.7 | 46.4 |
Relative | 7.3 | 140.5 | 18.7 |
52 week high/low | SEK19.6/SEK5.9 |
IRLAB Therapeutics has confirmed the FDA’s alignment with its proposed Phase III programme for mesdopetam in levodopa-induced dyskinesias (PD-LIDs), following receipt of the minutes from its end-of-Phase II (EoP2) meeting held last month. Notably, the FDA has agreed on the primary endpoint being the Unified Dyskinesia Rating Scale (UDysRS), on which mesdopetam demonstrated a statistically significant improvement (p=0.026) in the Phase IIb study (secondary endpoint of that study). IRLAB will now engage with European regulatory agencies to prepare for the Phase III trial. Following the positive endorsement from the FDA, we expect partnering talks to intensify in the coming weeks, with the partner taking on responsibility for further clinical development.
Y/E Dec | Revenue (SEKm) | EBITDA (SEKm) | PBT (SEKm) | EPS (öre) | P/E (x) | P/CF (x) |
---|---|---|---|---|---|---|
2022A | 61.3 | (108.3) | (113.1) | (218.0) | N/A | N/A |
2023A | 5.7 | (176.5) | (177.8) | (343.0) | N/A | N/A |
2024E | 0.0 | (185.5) | (191.3) | (369.0) | N/A | N/A |
2025E | 0.0 | (173.6) | (189.7) | (366.0) | N/A | N/A |