Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q1 2024 Earnings Presentation
43 slides from Irlab Therapeutics Ab Class A's earnings presentation, May 1, 2024
Slide 1: World-leader in drug development in Parkinson's: IRLAB, Q1 2024
World-leader in drug development in Parkinson’s: Reducing the burden and transforming lives IRLAB, Q1 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 Q1 business 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
Key highlights Collaboration with MSRD/Otsuka, funding IRL757 through IRL757 program fully clinical Proof-of-Concept financed through PoC Phase III study Successful End-of-Phase 2-meeting with FDA for mesdopetam program confirmed Regulatory approvals New insights from the Phase IIb study with pirepe
Slide 5: IRL757 fully financed through Proof-of-Concept
Q1 update IRL757 fully financed through Proof-of-Concept Development collaboration with MSRD/Otsuka Phase I progression • Financing of IRL757 now secured beyond the • CRO contracted and study start expected in Phase I funded by The Michael J. Fox May 2024 Foundation through clinical Proof-of-Concept
Slide 6: IRL757 development collaboration with MSRD/Otsuka signed
Q1 update IRL757 development collaboration with MSRD/Otsuka signed 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 payme
Slide 7: Multiple positive aspects of the IRL757 agreement
Q1 update Multiple positive aspects of the IRL757 agreement 1) Brings near term cash flow to IRLAB – up-front + milestones – 8.5 MUSD 2) Secures full financing of the Development activities through PoC in two populations; Parkinson’s and Alzheimer’s disease 3) Provides additional external validation
Slide 8: Continued progress with mesdopetam
Q1 update Continued progress with mesdopetam PD-LIDs – progress towards phase III • Successful End-of-Phase 2 meeting with the FDA • Alignment on Phase III program • Alignment on the path forward towards NDA filing for market approval • Continued high intensity BD activities PD-P – progress in precl
Slide 9: Pirepemat regulatory update
Q1 update Pirepemat regulatory update Clinical trial progress Implications • REACT-PD – a pioneering study in a new • High probability to detect treatment effects with patient population lower sample size • Analyses of blinded data show • Reassessment of sample size • Stabilised patient recruitment
Slide 10: Operational highlights preclinical projects
Q1 update Operational highlights preclinical projects IRL942 IRL1117 • CMC work to develop API route and DP • CMC work to develop manufacturing route manufacturing ongoing ongoing • Anticipated Phase I ready during end of 2024 • Anticipated Phase I readiness end 2024 or or in the beginning of 2025 d
Slide 11: Participation and presentation at scientific meetings and financial conferences
Q1 update Participation and presentation at scientific meetings and financial conferences • Two posters presented at 18th International Conference on Alzheimer’s & Parkinson’s Diseases in Lisbon March 5-9, 2024. • REACT-PD – A Randomized, Placebo-Controlled Phase IIb Trial Evaluating the Efficacy of
Slide 12: R&D update
am | TRLAB It R&D update
Slide 13: Highly successful regulatory validation of R&D during the period
Highly successful regulatory validation of R&D during the period • End-of-Phase 2-meeting with FDA for mesdopetam • Clear path to NDA • New insights from the Phase IIb study with pirepemat • Approvals for refinement of study protocol, sample size and statistical considerations • Regulatory approval
Slide 14: 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 Psychosi
Slide 15: Mesdopetam
Mesdopetam IRL790 Treating levodopa-induced dyskinesias (PD-LIDs) through a novel mechanism
Slide 16: 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) 16
Slide 17: Mesdopetam - strong progress in Q1
Q1 update Mesdopetam - strong progress in Q1 LIDs • FDA End-of-Phase 2 meeting written minutes • Confirmed alignment between the agency and the company with regards to Phase III program; and • Road map to NDA filing is clear • Preparations for interactions with European Regulatory Agencies before Ph
Slide 18: Mesdopetam - progress in Q1
Q1 update Mesdopetam - progress in Q1 PD-P • In March a scientific article in the journal Neurotherapeutics* reported on the anti- psychotic effect of mesdopetam in a preclinical model of Parkinson’s disease psychosis (PD-P) Mesdopetam • Suppresses abnormal signalling; and • Restores signal complexi
Slide 19: 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 20: 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 A huge unmet need one of 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 21: 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 21
Slide 22: Pirepemat project progress in Q1
Pirepemat project progress in Q1 Pirepemat has potential to be the first treatment in a new class of drugs designed to improve balance and reduce falls and fall injuries in people living with Parkinson’s disease REACT-PD - Phase IIb study run in France, Germany, the Netherlands, Poland, Spain and Sw
Slide 23: IRL757 – treatment of apathy
IRL757 – treatment of apathy Apathy: loss of initiative, • A novel first-in-class treatment for apathy in neurological interest, and emotional disorders expression/responsiveness • Phase I SAD/MAD fully funded by Michael J Fox Foundation • Funding through proof-of-concept secured through collaborati
Slide 24: 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 • Several million US and EU citizens may be affected by people with dementia. apathy • Apathy
Slide 25: IRL757 project progress in Q1
IRL757 project progress in Q1 • Phase I ready after successfully completing the CMC development and regulatory preclinical studies • Funding to conduct the Phase I study (including SAD, MAD and Food interaction) with IRL757 is secured in through The Michael J. Fox Foundation • regulatory approval fo
Slide 26: 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 27: Innovative preclinical pipeline with first-in-class NCEs
Innovative preclinical pipeline with first-in-class NCEs IRL942 IRL1117 Improvement of cognitive Next generation Parkinson’s function treatment Memory, perception, Once-daily attention, reasoning, Parkinson’s hallmark symptoms problem-solving and (tremor, rigidity, bradykinesia) decision-making With
Slide 28: 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 Cognition encompasses all decline (CDC) aspects of intellectual • Studies demonstr
Slide 29: IRL942 project progress in Q1
IRL942 project progress in Q1 • • • 29
Slide 30: 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 80 Vehicle new class for the treatment of the hallmark symptoms IRL1117 0.1μmol/ kg of Parkinson’s. 60 • Once daily treatm
Slide 31: IRL1117 project progress in Q1
Preclinical & IRL1117 project progress in Q1: 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 Models of PD signs of to
Slide 32: Finance report Q1 2024
Finance report Q1 2024 • Highlights and summary • Analyst coverage
Slide 33: Multiple positive aspects of the IRL757 agreement
Multiple positive aspects of the IRL757 agreement 1) Brings near term cash flow to IRLAB – up-front + milestones – 8.5 MUSD 2) Secures full financing of the Development activities through PoC in two populations; Parkinson’s and Alzheimer’s disease 3) Provides additional external validation of our R&
Slide 34: MJFF and MSRD supports IRL757 through value creating activities
MJFF and MSRD supports IRL757 through value creating activites Launch 100% MSRD supports IRL757 through 80% clinical PoC 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 35: Financial highlights of Q1, 2024
Financial highlights of Q1, 2024 • Cash position SEK 73 million (including MSRD cash is ca SEK106m) • Investing in progressing mesdopetam towards Phase III • Increase in cost compared to Q4 2023 is mainly due to cost according to plan relating to the Phase IIb study with pirepemat and investments in
Slide 36: Financial summary of Q1, 2024
Financial summary of Q1, 2024 Q1 2024 Q1 2023 Net sales - - Operating profit - 37.6m - 59.5m Earnings per share before and after dilution, SEK - 0.75 - 1.15 Cash and cash equivalents 73.1m 210.1m Cash flow from operating activities - 38.2m - 41.5 Average number of employees 32 31 Share price at the
Slide 37: Analyst coverage
Analyst coverage • Fredrik Thor and Kevin Sule +46 (0) 545 013 30 info@redeye.se • Dr Gonzalo Artiach Castañón +46 (0)8 566 286 00 • Soo Romanoff +44 (0)20 3077 5700 healthcare@edisongroup.com 37
Slide 38: Concluding words
am | TRLAB It Concluding words
Slide 39: World leading portfolio transforming treatment for people living with Parkinson's
Portfolio World leading portfolio transforming treatment for 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 40: Key highlights
Key highlights Collaboration with MSRD/Otsuka, funding IRL757 through IRL757 program fully clinical Proof-of-Concept financed through PoC Phase III study Successful End-of-Phase 2-meeting with FDA for mesdopetam program confirmed Regulatory approvals New insights from the Phase IIb study with pirepe
Slide 41: Intensive Business Development efforts
Intensive Business Development efforts Following the Awareness of IRLAB Continuous and Partnering opportunities successful collaboration and our development frequent dialogue with being evaluated across deal for IRL757, pipeline is increasing potential partners the portfolio the focus is mesdopetam
Slide 42: IRLAB – a world-leading portfolio in Parkinson's
IRLAB – a world-leading portfolio in Parkinson´s Validated business Organization Pioneering biology Broad & Solid Focused strategy model based on clinical positioned for & ISP proof-of-concept portfolio success Deep profound Discover and From discovery Five unique drug Experienced understanding of d
Slide 43: 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 is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson’s disease. The company has i