Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q4 2024 Earnings Presentation
35 slides from Irlab Therapeutics Ab Class A's earnings presentation, 2025
Slide 1: World-leader in drug development in Parkinson's
World-leader in drug development in Parkinson’s: Reducing the burden and transforming lives IRLAB, Q4 2024
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 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 and after Q4 2024
Key highlights in and after Q4 2024 The company received USD 2.5 million in conjunction with first dosing in a Phase I study with IRL757 in healthy older adults IRL757 progress according to plan – fully funded through Positive results in the Phase I studies support the continued clinical PoC develop
Slide 6: Important events in and after Q4 2024: Mesdopetam
Important events in and after Q4 2024 Mesdopetam • Positive feedback from the regulatory authorities in Portugal and Germany - a consensus was reached on key aspects of the phase III program • Market and payor research confirms significant market potential for mesdopetam both in the US and Europe •
Slide 7: Important events in and after Q4 2024: Pirepemat and IRL757
Important events in and after Q4 2024 Pirepemat • The last patient completed the full treatment period in the Phase IIb study with pirepemat, REACT-PD - topline data is expected in the first quarter of 2025 IRL757 • The company received positive data from the first part of the Phase I study with the
Slide 8: Presentations in and after Q4 2024
Presentations in and after Q4 2024 • IRLAB presented at investor events during the period and after to communicate updates of the company’s strategy and pipeline • Redeye Neurology Theme Event – October • BioStock Life Science Summit 2024 – October • Redeye Technology & Life Science Day – December •
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
Slide 11: Mesdopetam (IRL790)
Mesdopetam (IRL790) Potential for patent- First in class- a novel Inhibiting dopamine D3 based exclusivity into mechanism receptors the 2040s Lead indication – levodopa-induced dyskinesias (PD- LIDs) 11
Slide 12: Continued progress with mesdopetam
Continued progress with mesdopetam PD-LIDs –phase III program progress • Scientific advice with European regulatory agencies in preparation for Phase III • Market research/Health provider activities for positioning of mesdopetam and input to the design of the Phase III program • Development of IPR –
Slide 13: Pirepemat
Pirepemat IRL752 • A treatment to improve balance and reduce falls in Parkinson’s (PD-Falls) • Ongoing randomized, placebo-controlled Phase IIb clinical trial
Slide 14: 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 14
Slide 15: Pirepemat - in development to improve balance and reduce falls in Parkinson's
Pirepemat - in development to improve balance and reduce falls in Parkinson’s • Reducing falls is the greatest medical need and one of the most complicating aspects of Parkinson’s A huge unmet need • 45% of individuals with Parkinson’s fall recurrently1 • Cost of a fall injury approx. 30 000 USD in
Slide 16: 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
Slide 17: 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 18: IRL757 project progress in Q4
IRL757 project progress in Q4 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 19: Preclinical projects
Preclinical projects IRL942 Clinical candidate - Improve cognitive function IRL1117 Clinical candidate - Once-daily oral treatment of Parkinson’s without troublesome complications
Slide 20: 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 21: 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 22: IRL942 project progress in Q4
IRL942 project progress in Q4 Current status • • • 22
Slide 23: 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 24: IRL1117 project
IRL1117 project 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 25: Finance report Q4 2024
Finance report Q4 2024 • Highlights and summary • Analyst coverage
Slide 26: Financial highlights of Q4, 2024
Financial highlights of Q4, 2024 • Cash position SEK 67 million, whereof roughly SEK 17 million is prepayments from MJFF and MSRD/Otsuka • Sustained high activity, and thus cost, related to IRL757, which are fully financed by MJFF and MSRD/Otsuka • IRLAB’s own cost continues to decrease and is now w
Slide 27: Financial summary of Q4, 2024
Financial summary of Q4, 2024 Q1-Q4 Q1-Q4 2024 2023 Net sales, SEK 94.6m 5.7m Operating profit, SEK - 75.1m - 180.8m Earnings per share before and after dilution, SEK - 1.6 - 3.43 Cash and cash equivalents, SEK 66.9m 111.3m Cash flow from operating activities, SEK - 65.6m - 164.9m Average number of
Slide 28: Analyst coverage
Analyst coverage • Fredrik Thor +46 (0) 545 013 30 info@redeye.se • Alexander Krämer +46 (0)8 566 286 00 • Arron Aatkar +44 (0)20 3077 5700 healthcare@edisongroup.com 28
Slide 29: Concluding words
am | TRLAB It Concluding words
Slide 30: 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 31: Key highlights in and after Q4 2024
Key highlights in and after Q4 2024 The company received USD 2.5 million in conjunction with first dosing in a Phase I study with IRL757 in healthy older adults IRL757 progress according to plan – fully funded through Positive results in the Phase I studies support the continued clinical PoC develop
Slide 32: 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 33: Multiple possibilities for high value creation in the project portfolio during the next 12-18 months
Multiple possibilities for high value creation in the project portfolio during the next 12-18 months • BD activities Mesdopetam • Initiation of the Phase III program • Top-line data Phase IIb study in PD-Falls Pirepemat • BD activities • Completion of Phase I studies (SAD/MAD, food interaction & hea
Slide 34: 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 35: 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