Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q4 2023 Earnings Presentation
41 slides from Irlab Therapeutics Ab Class A's earnings presentation, February 2024
Slide 1: World-leader in drug development in Parkinson's: Reducing the burden and transforming lives
World-leader in drug development in Parkinson’s: Reducing the burden and transforming lives IRLAB, Q4 2023
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 Q4 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: Operational highlights in Q4, 2023: Mesdopetam
Operational highlights in Q4, 2023 Q4 update Mesdopetam • In October initiation of a collaboration with Clintrex (US regulatory/clinical strategy advisors) and with ProPharma Group (US regulatory agent) to prepare for End-of-Phase II meeting with the FDA • In mid-December submission of application f
Slide 5: Operational highlights in Q4, 2023: Pirepemat
Operational highlights in Q4, 2023 Q4 update Pirepemat • IRLAB is granted additional patent of the drug used in the ongoing clinical development program. The patent is predicted to expire in 2038, and with the potentialgrant of supplementary protection certificates(SPCs) or patent term extension (PT
Slide 6: Operational highlights in Q4, 2023: IRL757
Operational highlights in Q4, 2023 Q4 update IRL757 • Completion of preclinical development work and initiation of compilation of data to seek regulatory approval (CTA) to initiate clinical phase I studies • IRLAB was selected to receive a grant of 2 million USD from The Michael J. Fox Foundation to
Slide 7: Operational highlights in Q4, 2023: Business development and financing
Operational highlights in Q4, 2023 Q4 update Business development and financing • Capital Markets Day in October in Stockholm – presentation of portfolio development and growth strategy • Participation in BioEurope in Nov. Follow-up discussions are ongoing. • Investors meetings – continued financing
Slide 8: Operational highlights in Q4, 2023: Management and operations
Operational highlights in Q4, 2023 Q4 update Management • IRLAB extended CEO appointment in December Operations • Fredrik Hansson, Director of Clinical Science & Biometrics, joins the company on Jan 1 8
Slide 9: Operational events after end of period: Pirepemat
Operational events after end of period Q3 update Pirepemat • New insights generated in the phase IIb study, React-PD • One-month baseline - fall rates higher and more stable than anticipated • Steady recruitment rate following opening of all centers (from May 2023) • Patient feed-back positive and r
Slide 10: Operational events after end of period: Science
Operational events after end of period Science • Two abstracts accepted for presentation 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 pirepemat on Falls Frequ
Slide 11: R&D update
7 IRLAB R&D update
Slide 12: The most bothersome symptoms according to people with Parkinson's
The most bothersome symptoms according to people with Parkinson’s What bothers people with Parkinson’s disease the most ? Self-reported, n=25 000 (the Fox Insight project, Michael J. Fox Foundation) Most frequent bothersome symptoms • Balance/instability • Hallmark symptoms • Tremor • Rigidity • Bra
Slide 13: Parkinson's disease progresses over time – symptoms and complications expand
Parkinson’s disease progresses over time –symptoms and complications expand Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive Hallmark symptoms: impairment Apathy Hallucinations • Tremors Balance and falls Confusion Freezing when Motor • Bradyki
Slide 14: World-leading portfolio to improve the treatment of Parkinson's
World-leading portfolio to improve the Parkinson’s and 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 15: Mesdopetam (IRL790)
Mesdopetam (IRL790) • Mesdopetam: to treat levodopa-induced dyskinesias (PD-LIDs) through a novel mechanism
Slide 16: Mesdopetam (IRL790)
Mesdopetam (IRL790) First in class- a novel Inhibiting dopamine D3 Patent-based exclusivity mechanism receptors into the 2040s Lead indication – levodopa-induced dyskinesias (PD- LIDs) 16
Slide 17: Mesdopetam project progress in Q4
Mesdopetam project progress in Q4 Mesdopetam has potential to be the first treatment in a new class of drugs designed to treat levodopa induced dyskinesias (PD-LIDs) • End-of-Phase 2 meeting with the FDA on Feb 20,2024 • In collaboration with clinical and regulatory experts, IRLAB is preparing for t
Slide 18: Growing body of clinical evidence supporting a novel treatment of dyskinesia in Parkinson's
Growing body of clinical evidence supporting a novel Mesdopetam treatment of dyskinesia in Parkinson’s Clinical studies of mesdopetam Completed Ongoing Planned Phase IIb PD-LIDs Phase I: SAD Phase Ib Phase IIa Phase I DDI Pivotal study program PD- +MAD PD-LIDs* PD-LIDs Phase I HMB LIDs Phase I speci
Slide 19: Pirepemat (IRL752)
Pirepemat (IRL752) • Pirepemat - a treatment to improve balance and reduce falls in Parkinson’s (PD-Falls) • Ongoing randomized, placebo-controlled Phase IIb clinical trial
Slide 20: Why preventing falls in Parkinson's?
Why preventing falls in Parkinson’s? Pirepemat Reducing falls is the greatest medical need and one of the worst aspects of Parkinson’s. • Prospective studies report that 70% of people with Parkinson’s have at least one fall in a year and about 45% fall recurrently • Median survival in patients that
Slide 21: Pirepemat (IRL752)
Pirepemat (IRL752) First in class- a novel Inhibiting alpha 2 and Patent-based exclusivity mechanism serotonin 7 receptors into the 2040s Objective – reduce falls in Parkinson’s disease 21
Slide 22: Clinical development path for pirepemat: Improvement of balance and falls
Clinical development path for pirepemat: Pirepemat Improvement of balance and falls Completed Ongoing Planned Phase IIa Phase IIb Phase I: SAD+MAD PD-cortical Pivotal studies PD-Falls impairment* Well tolerated Well tolerated Evaluates effects on Good pharmaco- Improves: o Falls frequency ki
Slide 23: Pirepemat project progress in Q4
Pirepemat project progress in Q4 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 • The ongoing Phase IIb study is recruiting, in France, Germany, the Netherlands, Poland
Slide 24: 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 • 45% of individuals with Parkinson’s fall recurrently A huge unmet need • Cost of a fall injury approx. 30 000 USD in patients > 65 PD-Falls population years EU5 • There is no available treatment despite the lar
Slide 25: Preclinical projects
Preclinical projects IRL757 Clinical candidate Treat apathy IRL942 Clinical candidate Improve cognitive function and brain health IRL1117 Clinical candidate Once-daily oral treatment of Parkinson’s without troublesome complications
Slide 26: Preclinical projects in development
Preclinical projects in development Preclinical projects IRL757 IRL942 IRL1117 Treatment for Once-daily treatment of Parkinson’s apathy Improvement of cognitive function (tremor, rigidity, bradykinesia) without treatment-related complications Loss of initiative, interest, and Memory, perception, att
Slide 27: IRL757 & IRL942 project progress in Q4
IRL757 & IRL942* 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 • Now Phase I ready after successfully completing the preclinical studies and CMC development required • Funding to conduct the Phase I
Slide 28: IRL1117 project progress in Q4
IRL1117 project progress in Q4 ) 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 • The drug should be taken once daily and avoids the 60 troublesom
Slide 29: Finance report Q4 2023
Finance report Q4 2023 • Highlights and summary • Analyst coverage
Slide 30: Financial highlights of Q3 2023
Financial highlights of Q3 2023 • Cash position SEK 111 million • Investing in progressing mesdopetam towards Phase III • Investing in the Phase IIb with pirepemat according to plan - lower cost in Q4 than in Q3 • Maintaining investment in preclinical development, advancing IRL757 and IRL942 and IRL
Slide 31: Financial summary of fourth quarter
Financial summary of fourth quarter Q4 2023 Q4 2022 Net sales - 1.2 12.2m Operating profit - 35.6m - 33.1m Earnings per share before and after dilution, SEK - 0.67 - 0.64 Cash and cash equivalents 111.3m 252.8 Cash flow from operating activities - 33.9m - 37.9 Average number of employees 31 30 Share
Slide 32: 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 32
Slide 33: Concluding words
7 IRLAB Concluding words
Slide 34: Our strategy
Our strategy • Addressing all stages of Parkinson’s disease and other CNS disorders • Discovering novel candidate drugs (CDs) with our ISP platform • True innovation • Higher success rate • Strong IP position • Developing CDs from discovery to Proof-of-Concept (PoC) • Seeking partnering after PoC 34
Slide 35: Key developments and growth of the project portfolio during 2023
Key developments and growth of the project portfolio during 2023 • Mesdopetam • IRL1117 • Phase IIb read out • CD selection and initiation of preclinical • Secured full ownership and rights to the product development • Phase III readiness • IRL942 • End-of-Phase 2 meeting with the FDA on Feb 20, 202
Slide 36: Development portfolio transforming treatment of people living with Parkinson's
Development portfolio transforming treatment of 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) ready Feb 20, 2024: (IRL790) D3 antagonist End-of-Phas
Slide 37: Business development efforts
Business development efforts Awareness of IRLAB and Continuous and frequent Partnering opportunities Near term focus on the development pipeline dialogue with potential being evaluated across mesdopetam and IRL757 is increasing partners the portfolio 37
Slide 38: Our key priorities are focused on value-creating activities
Our key priorities are focused on value-creating activities Clinical development • End-of-Phase 2 meeting with the FDA to define the Phase III program for mesdopetam • Complete recruitment for the Phase IIb study of pirepemat and drive for completion of the study • Initiate Phase I study with IRL757
Slide 39: Multiple possibilities for high value creation in the project portfolio
Multiple possibilities for high value creation in the project portfolio during the next 18 months Mesdopetam • End-of-Phase 2 meeting with the FDA • BD activities for Phase III Pirepemat • Completion of the Phase IIb study in PD-Falls • BD activities for Phase III IRL757 • Completion of First in Hum
Slide 40: IRLAB – a world-leading portfolio in Parkinson's to reduce the burden
IRLAB – a world-leading portfolio in Parkinson´s to reduce the burden and transforming lives Validated business model Organization Pioneering biology Broad & Solid Focused strategy based on clinical proof- positioned for & ISP of-concept portfolio success Deep profound Discover and From discovery Fi
Slide 41: 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