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World leader - developing new treatments for Parkinson's disease IRLAB, Q2 2025 ©2025 IRLAB Therapeutics AB (publ), All rights reserved ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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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, employees, affiliates or representatives make any representation or warranty, expressed or implied, as to the accuracy, reliability or completeness of any of the information or projections in the Presentation, or any other written or oral communication transmitted or made available at any time. IRLAB expressly disclaims any and all liability relating to or resulting from the use of such information or communication. The information contained in this Presentation is subject to change, completion or amendment without notice. Neither this Presentation nor its delivery to any person shall constitute an offer to license, sell or enter into any transaction or commercial agreement. This Presentation does not constitute advice or a recommendation regarding any securities and is not an offer to sell or a solicitation to buy any securities. Recipients shall be aware of the fact that IRLAB’s shares are listed at Nasdaq Stockholm Main Market. 2
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Today’s agenda 3 News in the period 1 R&D update Financials Concluding words Q&A session 2 3 4 5 Kristina Torfgård, CEO Nicholas Waters, EVP Head of R&D Viktor Siewertz, CFO ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Key highlights in and after Q2 2025 4 New patent granted for mesdopetam – expands patent protection in the US and expires in the mid 2040s Groundbreaking data – potential for a new class of CNS drugs Strengthening the value of mesdoptam Positive Phase I results on IRL757 support ongoing development Data presented at AD/PD support treatment strategies for PD with "cortical enhancers" - pirepemat, IRL757 and IRL942 IRL757 progresses according to plan – fully funded through clinical PoC ©2025 IRLAB Therapeutics AB (publ), All rights reserved A rights issue provided the company SEK 115.7 million before issue costs and set-off of loans Strengthened financial position – opportunities for value creation
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R&D update 5
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Mesdopetam IRL790 Treating levodopa-induced dyskinesias (PD-LIDs) through a novel mechanism – Dopamine D3 receptor antagonism ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Mesdopetam (IRL790) 7 First in class- a novel mechanism Inhibiting dopamine D3 receptors Potential for patent- based exclusivity towards mid 2040s Lead indication – levodopa-induced dyskinesias (PD-LIDs) ©2025 IRLAB Therapeutics AB (publ), All rights reserved “Pipeline-in-a-Pill” - life cycle management opportunities • Parkinson disease psychosis • Prevention of levodopa-induced dyskinesia • Optimization of levodopa treatment without driving dyskinesia • Tardive dyskinesia
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Regulatory validation and value creation Q1 & Q2 8 Regulatory guidance and payor input on mesdopetam phase III program achieved • Scientific advice with EMA and local EU regulatory agencies in line with FDA advice on design of Phase III program Important value creating information & patents granted in the US • Market research/Health provider activities guiding value proposition and positioning of mesdopetam provides input to the design of the Phase III program • An additional composition of matter patent has been granted in the US • The patent is previously granted in Europe • This patent family provides exclusive market protection for mesdopetam but also protect the process for its production • The granted patents expand the already strong patent protection for mesdopetam. • There is therefore potential for market exclusivity towards the mid 2040s in large and important markets ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Mesdopetam fills the gap between current levodopa based and invasive treatments 9 payor position (ref: NICE) Advanced levodopa-responsive Parkinson’s disease with severe motor fluctuations and hyperkinesia or dyskinesia when available combinations of Parkinson medicinal products have not given satisfactory results DBS (65 kUSD) Duodopa (28 kGBP/yr) Produodopa (31 kGBP/yr) Mesdopetam Fills the gap and can delay invasive treatments PD Disease severity Pharmacological Invasive Levodopa adjustments + other concomitant treatments ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Pirepemat IRL752 • A treatment reduce falls in Parkinson’s (PD-Falls) • Full program from preclin through a randomized, placebo- controlled dose-finding Phase IIb clinical trial completed ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Pirepemat (IRL752) 11 First in class - a novel mechanism Inhibiting alpha 2 and serotonin 7 receptors Potential for patent- based exclusivity towards mid-2040s Objective – reduce falls in Parkinson’s disease ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Pirepemat - in development to reduce falls in Parkinson’s 12 Reducing falls is the greatest medical need and one of the most complicating aspects of Parkinson’s • 45% of individuals with Parkinson’s fall recurrently • Cost of a fall injury approx. 30 000 USD in patients > 65 years (CDC) • About USD 80 billion was spent in the US (2020) for non-fatal falls in older adults Source: 1. Datamonitor [Based on the number of treated patients in the 8 Major Markets (China, France, Germany, Italy, Japan, Spain, UK and the US] Source: 2. https://pubmed.ncbi.nlm.nih.gov/39029927/ EU5 (DE, ES, FR, IT, UK) US JP CN A huge unmet need Recurrent fallers ~ 345,000 ~ 465,000 ~ 1,777,000 ~ 226,000 ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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13 Reduction in relative fall rate vs. pirepemat plasma concentration [exposure]: PK-PD 22 51% 30 31 40 50 60 70 80 90 100 baseline month 1 month 2 month 3 low n=20 medium n=20 high n=19 placebo n=30 % Improvement p = 0.037 over study period PK analysis set, P-value based on negative binomial regression model Prespecified assessment of exposure vs. efficacy - therapeutic window Study participants were assigned to three groups of same size based on plasma concentration [exposure] and compared to the 30 participants receiving placebo ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Developments during Q2 14Full list of inclusion/exclusion criteria is available on https://clinicaltrials.gov/ct2/show/NCT05258071 ©2025 IRLAB Therapeutics AB (publ), All rights reserved Status and ongoing activities • Based on the dose finding phase IIb data a strengthened development plan in place • Preparing for a decision on the next step in the development of pirepemat – including; • Preparation for a clinical study with the aim to optimize the titration of individual dosages so that all treated individuals remain within the therapeutic window • These results will be crucial for designing a future Phase III program • Notice of allowance was granted for the new composition of matter patent for pirepemat in Canada • The new patent has previously been granted in the US, Europe, Japan and China • The exclusivity in the US and Canada is extended towards mid-2040s • A pan-European expert group is preparing a publication of the Phase IIb study results
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IRL757 – treatmentof apathy • A novel first-in-class treatment for apathy in neurological disorders Apathy: loss of initiative, interest, and emotional expression/responsiveness Addressable population: 2-7 million people ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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IRL757 is aimed at the huge untreated problem with apathy 16 Graph: from R. R. Tampi, Psychiatric Times, Vol 38, Issue 7, July 14, 2021 Huge unmet medical need • Several million US and EU citizens may be affected by apathy • Apathy occurs in 20-70% in people with PD and in 20-90% of people with AD and other CNS disorders Pathophysiological background • Disruption of frontal-subcortical neurocircuits are implicated in apathy* Loss of initiative, interest and emotional expression/ responsiveness, often found in people with dementia. Apathy • IRL757 has a unique ability to increase neuronal activity in frontal-subcortical neurocircuits • Potential for both symptomatic relief and disease modification * T.N Chase Neurotox Res (2011) 19:266–278, DOI 10.1007/s12640-010-9196-9 ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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IRL757 project progress in Q1 17 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/Otsuka funding IRL757 through a large signal finding study Status • Preclinical and clinical phase I studies successfully completed • The regulatory application for the clinical trial in individuals with Parkinson's disease and apathy is ready for submission to the European Medicines Agency (EMA) ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Preclinical projects IRL942 Clinical candidate - Improve cognitive function IRL1117 Clinical candidate - Once-daily oral treatment of Parkinson’s without troublesome complications ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Addressable population: 5.7 million people1 19 Memory, perception, attention, reasoning, problem-solving and decision-making IRL942 Improvement of cognitive function Once-daily Parkinson’s hallmark symptoms (tremor, rigidity, bradykinesia) Without treatment-related complications IRL1117 Next generation Parkinson’s treatment Status: Preclinical Development Status: Preclinical Development Source: 1. Datamonitor Addressable population: 5.8 million people1 Innovative preclinical pipeline with first-in-class NCEs ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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IRL942 to improve cognitive function in PD and other neurological indications 20 • Unmet need among a large population • 12 % of adults aged 65 years or more experience cognitive decline (CDC) • Studies demonstrate a high cumulative risk of dementia in people with PD. Point prevalence is 25–30%. • Among PD patients without dementia, approximately 25–30% have mild cognitive impairment (MCI), which is evident at the time of diagnosis in 10–20% of patients Cognition Cognition encompasses all aspects of intellectual functions and processes such as memory, perception, attention, reasoning, problem solving and decision-making. Impaired cognition is strongly associated to dementia. IRL942 shows a unique ability to activate frontal circuits and improve cognitive function in preclinical models Potential for both symptomatic relief and disease modification ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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IRL942 project progress in Q2 21©2025 IRLAB Therapeutics AB (publ), All rights reserved 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 Status • GMP manufacturing of the drug substance and development of the method for drug product production is soon completed • Due to priorities in the pipeline, we do not expect to initiate preparatory studies allowing for Phase I until H2 2026, at the earliest
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IRL1117 – potential to be the first drug in a new class to treat Parkinson’s 22©2025 IRLAB Therapeutics AB (publ), All rights reserved Status • IRL1117 is a potent dopamine D1 and D2 receptor agonist • The preclinical results from long-term treatment show that IRL1117 has full anti-Parkinson effect with clear differentiation vs. levodopa • Long-term studies show that IRL1117 provides full anti-Parkinson's effect without activating genes linked to the well known motor fluctuations and thus, IRL1117 does not cause such motorcomplications • Development of drug substance manufacturing on a larger scale (CMC work) ongoing • Preparations for the preclinical regulatory studies that are necessary for the start of Phase I are underway 0 20 40 60 80 Time (hours) Motor activation Vehicle IRL1117 0.1μmol/ kg 1 2 3 4 5 6 7 8 9 10
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Finance report Q2 2025 • Highlights and summary • Analyst coverage
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Financial highlights 24 • Cash position SEK 54 million. Roughly 56 million (gray bar in left graph below) will be added from the rights issue that was announced in Q2 and concluded in Q3. • External clinical cost continues to decrease. Most of the quarter’s cost occurred during April. • Partnering cost has increased and will remain quite high as the study with IRL757 advances. • Increased focus on cost control which will be maintained in the coming quarters with a focus on the study with IRL757, retain competence in the organization but keep external cost low. • Headcount remains stable at around 30 employees. Partnering cost: Cost for entering licensing agreements and costs which are covered by a corresponding revenue from partners. Gray bars indicate cash flow from share issues or licensing agreements ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Financial summary 25 Q1-Q2 2025 Q1-Q2 2024 Net sales, SEK 23.9m 42.8 Operating profit, SEK - 54.4m - 42.7m Earnings per share before and after dilution, SEK - 1.28 - 0.89 Cash and cash equivalents, SEK 53.6m 98.3m Cash flow from operating activities, SEK - 36.3m - 38.1m Average number of employees 31 32 Share price at the end of the period, SEK 3.92 13.25 ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Remarkable advances from 2013 until today 26 • The company started in 2013 with two preclinical projects and the development platform ISP • Today we have five projects, three of which are in clinical stage and some even in late clinical stage • Organizational momentum has been build going from a handful of part time employees to a team of roughly 30 highly skilled professional in a wide array of competences • 11 share issues, raising SEK 900 million • Five share issues in private setting • Six in the public setting • Roughly SEK 700 million acquired from BD activities to be used in the projects • The licensing of mesdopetam to Ipsen, including Ipsen’s direct cost for mesdopetam • The research collaboration with MSRD regarding IRL757 • Grants from The Michael J. Fox Foundation regarding IRL757 • Grants from Vinnova/Horizon 2020
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Concluding words
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28 Mesdopetam (IRL790) Discovery Preclinical Phase I Phase IIa Phase IIb Phase III Parkinson’s disease levodopa- induced dyskinesia (PD-LIDs) D3 antagonist Parkinson’s disease Psychosis D3 antagonist Pirepemat (IRL752) Parkinson’s disease impaired balance and falls PFC enhancer Parkinson’s disease Dementia PFC enhancer IRL757 Apathy in neurology IRL1117 Parkinson’s disease treatment 2025: Projected start of Phase III study program Next major event 2025: Completion of analyses and next steps 2025: initiate IND enabling studies Phase II ready Phase IIb Phase IIa Preclinical Phase III ready Phase I Q4 2025: Start of study in PD IRL942 Cognitive impairment in neurology 2026: Phase I readyPreclinical World leading portfolio of development programs for Parkinson’s disease ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Value creation milestones over the next 12-18 months 29 Mesdopetam Pirepemat Preclinical projects IRL757 • BD activities • Initiation of the Phase III program • Decision on next step – prepare for dose optimization study • BD activities • Start the study in PD-apathy (Phase Ib safety and efficacy signal finding) • IRL942: Phase I readiness • IRL1117: Phase I readiness, start of Phase I ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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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 originates from Nobel Laureate Prof Arvid Carlsson’s research group and the discovery of a link between brain neurotransmitter disorders and brain diseases. Mesdopetam (IRL790), under development for treating levodopa-induced dyskinesias, has completed Phase IIb and is in preparation for Phase III. Pirepemat (IRL752), currently in Phase IIb, is being evaluated for its effect on balance and fall frequency in Parkinson’s disease. IRL757, a compound being developed for the treatment of apathy in neurodegenerative disorders, is in Phase I. In addition, the company is also developing two preclinical programs, IRL942 and IRL1117, towards Phase I studies. IRLAB’s pipeline has been generated by the company’s proprietary systems biology-based research platform Integrative Screening Process (ISP). Headquartered in Sweden, IRLAB is listed on Nasdaq Stockholm (IRLAB A). Website: irlab.se | Follow us on LinkedIn >