Last close As at 05/08/2026
SEK1.39
▲ −0.01 (−0.43%)
Market capitalisation
SEK197m
Research: Healthcare
IRLAB Therapeutics has announced that IRL757, a drug candidate being developed for the treatment of apathy in Parkinson’s disease (PD) and other neurological conditions, is now Phase I-ready. Management is preparing the required documentation to submit a Phase I clinical trial application for regulatory approval, on track with the company’s previously disclosed guided timelines. The company has also reported that it has entered into a grant agreement with the Michael J. Fox Foundation (MJFF) for Parkinson’s Research, and will receive funding amounting to over $2m (c SEK20.2m) to support this programme. IRLAB will use the grant to conduct the Phase I trial for IRL757 in apathy, while also benefiting from the experience and expertise provided by the MJFF. As there are currently no approved therapies for apathy, and with support from the MJFF, which is the largest non-profit funder of PD research, we view this as a key opportunity for IRLAB to potentially address this unmet medical need.
Written by
IRLAB Therapeutics |
IRL757 Phase I-ready with support from MJFF |
Pipeline update |
Pharma and biotech |
22 December 2023 |
Share price performance
Business description
Analysts
IRLAB Therapeutics is a research client of Edison Investment Research Limited |
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IRLAB Therapeutics has announced that IRL757, a drug candidate being developed for the treatment of apathy in Parkinson’s disease (PD) and other neurological conditions, is now Phase I-ready. Management is preparing the required documentation to submit a Phase I clinical trial application for regulatory approval, on track with the company’s previously disclosed guided timelines. The company has also reported that it has entered into a grant agreement with the Michael J. Fox Foundation (MJFF) for Parkinson’s Research, and will receive funding amounting to over $2m (c SEK20.2m) to support this programme. IRLAB will use the grant to conduct the Phase I trial for IRL757 in apathy, while also benefiting from the experience and expertise provided by the MJFF. As there are currently no approved therapies for apathy, and with support from the MJFF, which is the largest non-profit funder of PD research, we view this as a key opportunity for IRLAB to potentially address this unmet medical need.
Year end |
Revenue (SEKm) |
PBT* |
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 |
7.2 |
(184.0) |
(3.55) |
0.0 |
N/A |
N/A |
12/24e |
0.2 |
(202.5) |
(3.90) |
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 announced that all preclinical studies have been completed for IRL757, which is being developed for the treatment of apathy; the candidate is now Phase I-ready. This condition is characterised by a lack of goal-directed activity, as well as lack of interest and emotional expression. It is prevalent in a range of neurological conditions including PD. While precise figures can vary (often complicated with co-symptoms of depression or anxiety, as well as due to variation in assessment tools), apathy prevalence rates in PD have been estimated to range from 12–70%. Prevalence rates for apathy associated with dementia have been estimated at 19–88%. According to management, overall apathy prevalence corresponds to over 20 million people in the US and Europe, and as there are currently no approved therapies for the treatment of apathy, we believe this could translate to a sizeable opportunity for IRLAB, provided the upcoming clinical trials are successful.
In a separate announcement, IRLAB has reported that the MJFF has awarded over $2m (c SEK20.2m) for the company to conduct a Phase I study of IRL757 in apathy. The grant comes from the MJFF’s Parkinson’s Disease Therapeutics Pipeline Program, which aims to advance preclinical/clinical testing of promising therapies to manage unmet needs for PD patients. We believe the grant adds confidence to IRLAB’s approach of tackling PD and, while we do not currently include IRL757 in our valuation for the company, we plan to incorporate the candidate once there is more visibility on a potential clinical programme.
We remind readers that IRLAB’s next most significant inflection points will likely be top-line readouts from the Phase IIb pirepemat trial for the treatment of impaired balance and falls in H1H24, and the outcome of the end-of-Phase II meeting with the FDA for mesdopetam, which is being developed for the treatment of levodopa-induced dyskinesias, a date for which is expected to be scheduled within Q124.
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Research: Healthcare
Recce recently reported that the Australian government has committed to providing up to A$55m in future cash rebates to reimburse upcoming R&D expenditure directed towards the company’s proprietary synthetic anti-infective programmes to June 2025. Notably, this binding agreement with the Australian government’s Department of Industry, Science and Resources (AusIndustry) extends the rebate programme that customarily reimburses 43.5% of eligible R&D expenditures incurred within Australia, to cover the anti-infective R&D activities Recce undertakes anywhere in the world. We view this as key given our expectation that US and global clinical trials will be needed to maximise the commercial potential of Recce’s products, notably lead candidate RECCE® 327 (R327). While our model already assumed the Australian government would reimburse 43.5% of Recce’s overseas R&D costs, there was a minor degree of uncertainty on whether this would be the case. Hence, the signing of this binding commitment with AusIndustry helps de-risk future funding needs for Recce as it advances its anti-infective programmes, notably R327 in sepsis/urosepsis and in complicated urinary tract infection (UTIs).