Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB is collaborating with two US-based advisory groups, Clintrex (clinical research company) and ProPharma Group (research consulting organisation) for expert guidance in preparing a brief package for mesdopetam to request an end-of-Phase II meeting with the US FDA. This development comes after the detailed analysis of Phase IIb trial data in August 2023, which confirmed the safety and tolerability of mesdopetam and indicated dose-dependent anti-dyskinetic and anti-Parkinsonian effects. We await the FDA’s approval for the progression of mesdopetam’s clinical development to a Phase III trial. Though mesdopetam’s development is the priority for IRLAB, the next key catalysts revolve around the anticipated top-line results for the Phase IIb pirepemat trial (H124) and the potential advancement of preclinical assets to Phase I ready stage during Q423–FY24.
Written by
IRLAB Therapeutics |
Collaboration to support FDA Ph III progression |
Company update |
Pharma and biotech |
10 October 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
||||||||||||||||||||||||||||||||||||||
IRLAB is collaborating with two US-based advisory groups, Clintrex (clinical research company) and ProPharma Group (research consulting organisation) for expert guidance in preparing a brief package for mesdopetam to request an end-of-Phase II meeting with the US FDA. This development comes after the detailed analysis of Phase IIb trial data in August 2023, which confirmed the safety and tolerability of mesdopetam and indicated dose-dependent anti-dyskinetic and anti-Parkinsonian effects. We await the FDA’s approval for the progression of mesdopetam’s clinical development to a Phase III trial. Though mesdopetam’s development is the priority for IRLAB, the next key catalysts revolve around the anticipated top-line results for the Phase IIb pirepemat trial (H124) and the potential advancement of preclinical assets to Phase Iready stage during Q423–FY24.
Year end |
Revenue (SEKm) |
PBT* (SEKm) |
EPS* |
DPS |
P/E |
Yield |
12/21 |
207.9 |
91.1 |
1.76 |
0.0 |
3.8 |
N/A |
12/22 |
61.3 |
(113.1) |
(2.18) |
0.0 |
N/A |
N/A |
12/23e |
6.9 |
(168.4) |
(3.25) |
0.0 |
N/A |
N/A |
12/24e |
0.2 |
(183.9) |
(3.55) |
0.0 |
N/A |
N/A |
Note: *PBT and EPS are normalised, excluding amortisation of acquired intangibles, exceptional items and share-based payments.
IRLAB has already commenced the preparatory activities with Clintrex and ProPharma on the required documentation for requesting an end-of-Phase II meeting with the US FDA. We believe the latest collaboration with the advisory groups will be helpful for regulatory processes and discussions given the technical expertise of these groups. As of now, the objective of the FDA meeting will be to obtain necessary guidance/alignment from before initiating Phase III. As part of the regulatory discussions, the US FDA will likely assess the Phase III plan, study protocols and review of the safety profile and effectiveness of the drug candidate, based on previous clinical trial data. Additionally, the regulatory authority might guide on the requirement for additional data to support future market application, if clinical endpoints are met.
Mesdopetam is in clinical development for levodopa-induced dyskinesias (PDLIDs); top-line data from the Phase IIb trial were released in January 2023. While the study did not meet its primary endpoint (change in daily hours of ‘ON time’ without troublesome dyskinesia versus placebo) with statistical significance, it did meet the secondary efficacy endpoint (demonstrating significant anti-dyskinetic effects measured by the Unified Dyskinesia Rating Scale, UDysRS). After this development, IRLAB secured full ownership of the mesdopetam project in August 2023, which was previously out-licensed to Ipsen (preclinical studies and Phase I, Ib, IIa and IIb trials were completed as part of this collaboration). In late August 2023, management shared additional details of the Phase IIb data (details in prior note), which showed dose-dependent anti-dyskinetic and anti-Parkinsonian effects. With the comprehensive data package now available, management believes the mesdopetam project is Phase III ready and plans to move forward with its development. We, therefore, believe that the outcome of this FDA meeting could represent a major catalyst for the company.
|
|
Research: Financials
Helios Underwriting reported H123 EPS of 5.7p, a meaningful turnaround from a 4.4p loss in H122 and a 4.9p loss in FY22. It benefited from a much-improved combined ratio of 88% (H122: 95%) and a turnaround in syndicate investment income, supported by 28% growth in gross written premiums (GWP). It recorded a 4.8% increase in underwriting capacity, to £310.8m, thanks to acquisitions and new investment. Group investment income lagged in H123 but is forecast to deliver strongly in H223 and into FY24. This resulted in a small reduction in our FY23 EPS forecast from 15.1p to 14.6p, but thanks to increases for FY24 and FY25, benefiting from share buybacks, our valuation remains unchanged at 252p/share, a 46% premium to our FY23e net asset value (NAV) and double the current share price. As the forced sell-off by Odey Asset Management is completed, a more liberal dividend policy and further buybacks should be supportive.