Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q2 2024 Earnings Presentation
39 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, Q2 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
Q2 business Today’s agenda update 1 News in the period Gunnar Olsson, 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: Key highlights in Q2 2024
Key highlights in Q2 2024 IRL757 is our third clinical Clinical Phase I study with IRL757 started - funded by The Michael J Fox Foundation project Collaboration with MSRD//Otsuka initiated – Takes IRL757 through IRL757 fully funded clinical Proof-of-Concept in apathy in Parkinson’s and Alzheimer’s t
Slide 5: IRL757 development collaboration with MSRD/Otsuka
Q2 update IRL757 development collaboration with MSRD/Otsuka Scope of the collaboration • Develop IRL757 through clinical Proof-of-Concept for the treatment of apathy in Parkinson´s and Alzheimer´s disease Secures financing through clinical Proof-of-Concept IRLAB MSRD • Receives up-front payment and
Slide 6: Multiple positive aspects of the MSRD/Otsuka agreement
Q2 update Multiple positive aspects of the MSRD/Otsuka agreement 1) Brings near term cash flow to IRLAB – up- front + milestones – 8.5 MUSD 2) Secures full financing of the Development activities Benchmark through PoC in two populations; Ca 25 MUSD is the average Parkinson’s and Alzheimer’s disease
Slide 7: Summary – project progresses in Q2 2024
Summary – project progresses in Q2 2024 Mesdopetam • Preparation for Phase III and support to BD activities Pirepemat • DSMB recommendation to drive Phase IIb study to completion without changes IRL757 • Phase I ongoing and collaboration with MSRD/Otsuka initiated IRL942 • Preclinical documetation c
Slide 8: Financing aspects in Q2 2024
Financing aspects in Q2 2024 • Up-front payment from MSRD/Otsuka - 3 million USD • 25 million SEK drawn from the loan facility provided by Fenja Capital • Full financing of project cost relating to IRL757 development Present financing takes the company through key value driving milestones • Mesdopet
Slide 9: Participation and presentation at investor meetings in Q2
Q2 update Participation and presentation at investor meetings in Q2 • Redeye Investor Forum – April • ABGSC Investor Days – May • Redeye Growth Day – May • Aktiespararna – Stora Aktiedagarna in June 9
Slide 10: R&D update
am | TRLAB It R&D update
Slide 11: World-leading portfolio to improve the treatment of Parkinson's
Parkinson’s and World-leading portfolio to improve the IRLAB’s portfolio treatment of Parkinson’s 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
Slide 12: Mesdopetam
Mesdopetam IRL790 Treating levodopa-induced dyskinesias (PD-LIDs) through a novel mechanism – Dopamine D3 receptor antagonist
Slide 13: 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) 13
Slide 14: Continued progress with mesdopetam
Q2 update Continued progress with mesdopetam PD-LIDs –phase III program progress • Preparation for interactions with European regulatory agencies ahead of Phase III start • Market research activities for positioning and input to the Phase III program • Current plans allows start of Phase III study s
Slide 15: 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 16: Pirepemat - in development to improve balance and reduce falls in Parkinson's
Pirepemat Pirepemat - in development to improve balance and reduce falls in Parkinson’s • Reducing falls is the greatest medical need and one of A huge unmet need the worst aspects of Parkinson’s • 45% of individuals with Parkinson’s fall recurrently EU5 • Cost of a fall injury approx. 30 000 USD in
Slide 17: 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 17
Slide 18: Pirepemat update
Pirepemat update Clinical trial progress Implications • REACT-PD – a pioneering study in a new patient • Anticipated completion of patient recruitment in population Q3 2024 • DSMB for REACT-PD executed the last pre- • Leading to top line data in the end of Q1 2025 specified review of the data integr
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
Slide 20: IRL757 is aimed at the huge untreated problem with apathy
Preclinical & IRL757 is aimed at the huge untreated 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 21: IRL757 project progress in Q2
IRL757 project progress in Q2 • Regulatory approval granted • Phase I study started • Funding to conduct the Phase I study with IRL757 is secured in through The Michael J. Fox Foundation • Collaboration started with MSRD/Otsuka funding IRL757 through proof-of-concept in Parkinson’s and Alzheimer’s d
Slide 22: Preclinical projects
Preclinical projects IRL942 Clinical candidate - Improve cognitive function and brain health IRL1117 Clinical candidate - Once-daily oral treatment of Parkinson’s without troublesome complications
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
Preclinical & IRL942 to improve cognitive function in PD 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 25: IRL942 project progress in Q2
IRL942 project progress in Q2 • • • 25
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 project progress in Q2
Preclinical & IRL1117 project progress in Q2: research projects Building a comprehensive preclinical efficacy, tolerability and DMPK package - Phase I ready end 2024/H1 2025 • Single dose behavioral response >24h • Improvement of motor deficits by IRL1117 over a period of 29 days (once-daily dosing)
Slide 28: Finance report Q2 2024
Finance report Q2 2024 • Highlights and summary • Analyst coverage
Slide 29: MJFF and MSRD supports IRL757 through value creating activities
MJFF and MSRD supports IRL757 through value creating activites Launch 100% MSRD supports IRL757 through clinical PoC 80% MJFF supports Mesdopetam 60% IRL757 through Phase I clinical studies Pirepemat 40% 20% 942 757 1117 0% Discovery Pre-clin Phase 1 Phase 2 Phase 3 For illustrative purposes only Fi
Slide 30: Financial highlights of Q2, 2024
Financial highlights of Q2, 2024 • Cash position SEK 98 million • Investing in progressing mesdopetam towards Phase III • Increase in cost compared to Q1 2024 is mainly due to cost related to IRL757, which are financed by MJFF and MSRD/Otsuka • In preclinical development, advancing IRL942 and IRL111
Slide 31: Financial summary of Q2, 2024
Financial summary of Q2, 2024 H1 2024 H1 2023 Net sales, SEK 42.8m 6.9m Operating profit, SEK - 42.7m - 104.4m Earnings per share before and after dilution, SEK - 0.89 - 2.01 Cash and cash equivalents 98.3m 156.4m Cash flow from operating activities - 38.1m - 94.3m Average number of employees 32 31
Slide 32: Analyst coverage
Analyst coverage • Fredrik Thor +46 (0) 545 013 30 info@redeye.se • Alexander Krämer +46 (0)8 566 286 00 • Soo Romanoff +44 (0)20 3077 5700 healthcare@edisongroup.com 32
Slide 33: Concluding words
am | TRLAB It Concluding words
Slide 34: World leading portfolio transforming treatment for people living with Parkinson's
World leading portfolio transforming treatment for Portfolio 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) Q4 2024: ready (IRL790) D3 antagonist Projected sta
Slide 35: Key highlights in Q2 2024
Key highlights in Q2 2024 IRL757 is our third clinical Clinical Phase I study with IRL757 started - funded by The Michael J Fox Foundation project Collaboration with MSRD//Otsuka initiated – Takes IRL757 through IRL757 fully funded clinical Proof-of-Concept in apathy in Parkinson’s and Alzheimer’s t
Slide 36: Intense Business Development activities
Intense Business Development activities Awareness of IRLAB and Continuous and frequent Partnering opportunities Present focus is our development pipeline dialogue with potential being evaluated across mesdopetam is increasing partners the portfolio 36
Slide 37: Multiple possibilities for high value creation in the project portfolio
Multiple possibilities for high value creation in the project portfolio during the next 12-18 months Mesdopetam • BD activities for Phase III • Completion of the Phase IIb study in PD-Falls Pirepemat • BD activities for Phase III IRL757 • Completion of First in Human Phase I study (SAD/MAD & food in
Slide 38: 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 39: Contact:
Contact: Gunnar Olsson, CEO, gunnar.olsson@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 originates from N