Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q3 2024 Earnings Presentation
35 slides from Irlab Therapeutics Ab Class A's earnings presentation, 2024
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, Q3 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 Q3 business update 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: Important events in and after Q3 2024
Important events in and after Q3 2024 Mesdopetam • A new patent was granted for mesdopetam, expanding the patent protection in Europe • Data from a meta-analysis of two studies evaluating the efficacy of mesdopetam was presented at the International Congress of Parkinson’s Disease and Movement Disor
Slide 6: Important events in and after Q3 2024
Important events in and after Q3 2024 IRL757 • Positive data reported in the first part (SAD) of the Phase I study with the drug candidate IRL757 • IRLAB to receive a milestone payment of USD 2.5 million in conjunction with first dosing in a Phase I study with IRL757 in healthy older adults 6
Slide 7: Presentations and interviews in and after Q3
Presentations and interviews in and after Q3 Q3 update 2024 • IRLAB presented at investor events during the period and after to communicate updates of the company’s strategy and pipeline • BioStock Investing in Life Science – September • Pareto Securities Health Care Conference – September • Redeye
Slide 8: Summary – project progresses in Q3 2024
Summary – project progresses in Q3 2024 Q3 update Mesdopetam • Preparation for Phase III - regulatory processes & health provider data Pirepemat • DSMB recommendation to drive Phase IIb study to completion without changes • Completion of patient enrollment in the Phase IIb study IRL757 • Phase I stu
Slide 9: R&D update
7 IRLAB 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 Q3 update 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 External val
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 - in development to improve balance and reduce falls in Parkinson's
Pirepemat - in development to improve balance and Pirepemat reduce falls in Parkinson’s • Reducing falls is the greatest medical need and one of A huge unmet need the most complicating aspects of Parkinson’s PD-Falls population • 45% of individuals with Parkinson’s fall recurrently EU5 • Cost of a f
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 15
Slide 16: Pirepemat update
Pirepemat update REACT-PD – a pioneering study in Implications recurrent fallers • Anticipated to top line data end of Q1 2025 Clinical trial progress • DSMB for REACT-PD executed the last pre- specified review of the data integrity and safety in late June & recommends the company to continue the st
Slide 17: 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 18: IRL757 is aimed at the huge untreated problem with apathy
IRL757 is aimed at the huge untreated Preclinical & research projects 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
Slide 19: IRL757 project progress in Q3
IRL757 project progress in Q3 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 20: Preclinical projects
Preclinical projects IRL942 Clinical candidate - Improve cognitive function IRL1117 Clinical candidate - Once-daily oral treatment of Parkinson’s without troublesome complications
Slide 21: 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 22: IRL942 to improve cognitive function in PD and other neurological indications
IRL942 to improve cognitive function in PD Preclinical & research projects 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 demonstr
Slide 23: IRL942 project progress in Q3
IRL942 project progress in Q3 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 24: 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 the treatment of the hallmark symptoms of Parkinson’s. Vehicle IRL1117 0.1μmol/ kg • Once daily treatment
Slide 25: IRL1117 project
IRL1117 project Preclinical & research projects 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
Slide 26: Finance report Q3 2024
Finance report Q3 2024 • Highlights and summary • Analyst coverage
Slide 27: Financial highlights of Q3, 2024
Financial highlights of Q3, 2024 • Cash position SEK 90 million, whereof roughly SEK 34 million is prepayment for cost that will be covered by 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 remains
Slide 28: Financial summary of Q3, 2024
Financial summary of Q3, 2024 Q1-Q3 Q1-Q3 2024 2023 Net sales, SEK 51.8m 6.9m Operating profit, SEK - 72.1m - 145.1m Earnings per share before and after dilution, SEK - 1.5 - 2.75 Cash and cash equivalents 90.4 118.8m Cash flow from operating activities - 43.0m - 131.0m Average number of employees 3
Slide 29: 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 29
Slide 30: Concluding words
7 IRLAB Concluding words
Slide 31: Key highlights in and after Q3 2024
Key highlights in and after Q3 2024 Q3 update The Phase IIb study with pirepemat, REACT-PD, is being completed after a positive opinion from the external safety committee progresses towards finalization and read out The last patient in the Phase IIb study with pirepemat enrolled: A reduction in the
Slide 32: World leading portfolio transforming treatment for people living with Parkinson's
World leading portfolio transforming treatment for Q3 update people living with Parkinson’s 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
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