Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q1 2025 Earnings Presentation
36 slides from Irlab Therapeutics Ab Class A's earnings presentation, Sep 1, 2025
Slide 1: World leader in developing new treatments for Parkinson's disease
World leader in developing new treatments for Parkinson's disease IRLAB, Q1 2025 ©2025 IRLAB Therapeutics AB (publ), All rights reserved
Slide 2: Disclaimer
Disclaimer This document, “IRLAB Therapeutics” (the “Presentation”), has been prepared by IRLAB Therapeutics AB (publ) (“IRLAB”) and is provided for informational purposes only. All information in this Presentation has been compiled in good faith by IRLAB. Neither IRLAB nor any of its directors, emp
Slide 3: Today's agenda
Today’s agenda 1 News in the period Kristina Torfgård, CEO 4 Concluding words 2 R&D update Nicholas Waters, EVP Head of R&D 3 Financials 5 Q&A session Viktor Siewertz, CFO ©2025 IRLAB Therapeutics AB (publ), All rights reserved 3
Slide 4: First-in-class drug candidates to treat Parkinson's during all stages of the disease
First-in-class drug candidates to treat Parkinson’s during all stages of the disease Initial symptoms before diagnosis Parkinson’s disease diagnosis IRLAB’s portfolio with first-in-class drug candidates to treat people with Parkinson’s during all stages of disease: Psychiatric Psychosis symptoms Cog
Slide 5: Key highlights in Q1 2025
Key highlights in Q1 2025 Strengthening the Positive feedback from the EMA – confirms alignment with the FDA on potential and value of Phase III for mesdopetam mesdoptam Positive Phase I results support continued development of IRL757 IRL757 progress according to plan – fully funded through IRL757 s
Slide 6: Important events in Q1 2025
Important events in Q1 2025 Mesdopetam • A waiver was received from the EMA regarding pediatric studies with mesdopetam in Parkinson’s Disease • Positive feedback was received from the EMA, confirming the alignment with the FDA regarding the Phase III program for mesdopetam • Preclinical data for me
Slide 7: Important events in Q1 2025
Important events in Q1 2025 Pirepemat • The last patient completed the full treatment period in the Phase IIb study with pirepemat, REACT-PD • Topline results from the Phase IIb study with pirepemat were reported, followed by additional positive efficacy data from the same study. In-depth analysis i
Slide 8: Presentations in and after Q1 2025
Presentations in and after Q1 2025 • IRLAB presented at investor events during the period and after to communicate updates of the company’s strategy and pipeline • Insight Direkt Dagen – January • Redeye Investor Forum – February • Aktiespararna’s Stora Aktiedagarna – March • Redeye Theme: Alzheimer
Slide 9: R&D update
am | TRLAB It R&D update
Slide 10: Mesdopetam
Mesdopetam IRL790 Treating levodopa-induced dyskinesias (PD-LIDs) through a novel mechanism – Dopamine D3 receptor antagonism ©2025 IRLAB Therapeutics AB (publ), All rights reserved
Slide 11: Mesdopetam (IRL790)
Mesdopetam (IRL790) Potential for patent- First in class- a novel Inhibiting dopamine D3 based exclusivity into mechanism receptors the 2040s “Pipeline-in-a-Pill” - life cycle management opportunities • Parkinson disease psychosis Lead indication – levodopa-induced • Prevention of levodopa-induced d
Slide 12: Regulatory validation on Phase III program
Regulatory validation on Phase III program Regulatory guidance and payor input on mesdopetam phase III program achieved • Scientific advice with EMA and local EU regulatory agencies in line with FDA advice • Market research/Health provider activities guiding positioning of mesdopetam and also provid
Slide 13: Mesdopetam fills the gap between current levodopa based and invasive treatments
Mesdopetam fills the gap between current levodopa based and invasive treatments PD Disease severity Pharmacological Invasive Levodopa adjustments + other concomitant treatments Produodopa Duodopa DBS (31 kGBP/yr) (28 kGBP/yr) (65 kUSD) payor position (ref: NICE) Advanced levodopa-responsive Mesdopet
Slide 14: Pirepemat
Pirepemat IRL752 • A treatment to improve balance and reduce falls in Parkinson’s (PD-Falls) • Ongoing randomized, placebo-controlled Phase IIb clinical trial ©2025 IRLAB Therapeutics AB (publ), All rights reserved
Slide 15: Pirepemat (IRL752)
Pirepemat (IRL752) Potential for patent- First in class- a novel Inhibiting alpha 2 and based exclusivity into mechanism serotonin 7 receptors the 2040s Objective – reduce falls in Parkinson’s disease ©2025 IRLAB Therapeutics AB (publ), All rights reserved 15
Slide 16: Pirepemat - in development to reduce falls in Parkinson's
Pirepemat - in development to reduce falls in Parkinson’s A huge unmet need Reducing falls is the greatest medical need and one of the most complicating aspects of Parkinson’s EU5 • 45% of individuals with Parkinson’s fall recurrently (DE, ES, FR, IT, • Cost of a fall injury approx. 30 000 USD in pa
Slide 17: Topline results of Phase IIb study
Topline results of Phase IIb study: Study topline results: • The fall rate decreased by 42% for those treated with pirepemat at a daily dose of 600 mg, but the effect was not statistically significant compared to placebo • The results on the cognitive scale (MoCA) indicated a meaningful improvement
Slide 18: Reduction in relative fall rate vs. pirepemat plasma concentration
Reduction in relative fall rate vs. pirepemat plasma concentration [exposure]: PK-PD 100 Prespecified assessment of exposure vs. efficacy - therapeutic window 90 Study participants were assigned to three groups of same size based on plasma 80 22 concentration [exposure] and compared to the 30 partic
Slide 19: IRL757 – treatment of apathy
IRL757 – treatment of apathy Apathy: loss of initiative, interest, and emotional expression/responsiveness • A novel first-in-class treatment for apathy in neurological disorders Addressable population: 2-7 million people ©2025 IRLAB Therapeutics AB (publ), All rights reserved
Slide 20: IRL757 is aimed at the huge untreated problem with apathy
IRL757 is aimed at the huge untreated problem with apathy Apathy Loss of initiative, interest and emotional Huge unmet medical need expression/ responsiveness, often found in people • Several million US and EU citizens may be affected by with dementia. apathy • Apathy occurs in 20-70% in people with
Slide 21: IRL757 project progress in Q1
IRL757 project progress in Q1 IRL757 has the potential to be the first drug in a new class to treat apathy in Parkinson’s and other neurological disorders • Funding to conduct the Phase I (SAD & MAD) study with IRL757 is secured in through the Michael J. Fox Foundation • Collaboration with MSRD/Otsu
Slide 22: Preclinical projects
Preclinical projects IRL942 Clinical candidate - Improve cognitive function IRL1117 Clinical candidate - Once-daily oral treatment of Parkinson’s without troublesome complications ©2025 IRLAB Therapeutics AB (publ), All rights reserved
Slide 23: Innovative preclinical pipeline with first-in-class NCEs
Innovative preclinical pipeline with first-in-class NCEs IRL942 IRL1117 Improvement of cognitive function Next generation Parkinson’s treatment Memory, perception, Once-daily attention, reasoning, Parkinson’s hallmark symptoms problem-solving and (tremor, rigidity, bradykinesia) decision-making With
Slide 24: IRL942 to improve cognitive function in PD and other neurological indications
IRL942 to improve cognitive function in PD and other neurological indications • Unmet need among a large population Cognition • 12 % of adults aged 65 years or more experience cognitive decline Cognition encompasses all (CDC) aspects of intellectual • Studies demonstrate a high cumulative risk of de
Slide 25: IRL942 project progress in Q1
IRL942 project progress in Q1 IRL942 has the potential to be the first drug in a new class to improve the cognitive function in people living with Parkinson’s and other neurological disorders Current status • Development in preclinical studies • GMP manufacturing of drug substance ongoing (CMC) • De
Slide 26: IRL1117 – potential to be the first drug in a new class to treat Parkinson's
IRL1117 – potential to be the first drug in a new class to treat Parkinson’s IRL1117 is a potent dopamine D1 and D2 receptor agonist with the potential to be the first drug in a new class for 80 Vehicle the treatment of the hallmark symptoms of Parkinson’s. IRL1117 0.1μmol/ kg • Once daily treatment
Slide 27: IRL1117 program
IRL1117 program Building a comprehensive preclinical efficacy, tolerability and DMPK package • Single dose behavioral response >24h • Improvement of motor deficits by IRL1117 over a period of 29 days (once-daily dosing) without signs of Models of PD tolerance or motor complications • Chronic treatme
Slide 28: Finance report Q1 2025
Finance report Q1 2025 • Highlights and summary • Analyst coverage
Slide 29: Financial highlights
Financial highlights • Cash position SEK 89 million, whereof roughly SEK 58 million is prepayments from MJFF and MSRD/Otsuka • As Phase I studies (SAD/MAD) with IRL757 has been finalized, cost related to IRL757, which are fully financed by MJFF and MSRD/Otsuka, has decreased slightly. Probable uptic
Slide 30: Financial summary
Financial summary Q1-Q4 Q1-Q4 2024 2023 Net sales, SEK 4.4m - Operating profit, SEK - 28.6m - 37.6m Earnings per share before and after dilution, SEK - 0.65 - 0.75 Cash and cash equivalents, SEK 88.6m 73.1m Cash flow from operating activities, SEK 6.3m - 38.2m Average number of employees 31 32 Share
Slide 31: Concluding words
am | TRLAB It Concluding words
Slide 32: World leading portfolio of development programs for Parkinson's disease
World leading portfolio of development programs for Parkinson’s disease Discovery Preclinical Phase I Phase IIa Phase IIb Phase III Next major event Parkinson’s disease levodopa- Phase III Mesdopetam induced dyskinesia (PD-LIDs) 2025: ready (IRL790) D3 antagonist Projected start of Phase III study P
Slide 33: Intensive Business Development efforts
Intensive Business Development efforts Following the successful Awareness of IRLAB and Continuous and frequent Partnering opportunities collaboration deal for our development pipeline dialogue with potential being evaluated across IRL757, the focus is on is increasing partners the portfolio mesdopet
Slide 34: Value creation milestones over the next 12-18 months
Value creation milestones over the next 12-18 months • BD activities Mesdopetam • Initiation of the Phase III program • Complete in-depth analyses of study data Pirepemat • Defining strategy forward • BD activities IRL757 • Start study in PD-apathy (safety and efficacy signal finding) • IRL942: Phas
Slide 35: IRLAB – a world-leading portfolio in Parkinson's
IRLAB – a world-leading portfolio in Parkinson´s Organization Pioneering biology Validated business Broad & Solid Focused strategy positioned for & ISP model portfolio success Deep profound Discover and From discovery Five unique drug Experienced understanding of develop treatments through Phase I a
Slide 36: Contact
Contact: Kristina Torfgård, CEO, kristina.torfgard@irlab.se Nicholas Waters, EVP and Head of R&D, nicholas.waters@irlab.se Viktor Siewertz, CFO, viktor.siewertz@irlab.se IRLAB discovers and develops a portfolio of transformative treatments for all stages of Parkinson’s disease. The company originate