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World leader - developing new treatments for Parkinson's disease IRLAB, Q3 2025 ©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 period1 R&D update Financials Concluding remarks Q&A session 2 3 4 5 Kristina Torfgård, CEO Nicholas Waters, EVP Head of R&D Kristina Torfgård, CEO ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Key highlights in and after Q3 2025 4 Clinical trial application for Parkinson’s study submitted to EMA - additional USD 4 million received for the IRL757 study funded by MSRD Focused on activities critical for development and partnerships IRL757 progresses according to plan – fully funded through clinical PoC New patent granted for mesdopetam in China – market exclusivity secured towards mid-2040s in all major markets The rights issue has provided capital and resources to reach the next stage in the development of IRL1117 and pirepemat Strengthening the value of mesdoptam ©2025 IRLAB Therapeutics AB (publ), All rights reserved Gustaf Albèrt was appointed new CFO Starts on November 17, 2025
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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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LIDs market characteristics - Q3 update 7 Key market characteristics and opportunity • Market research shows that mesdopetam has great potential in the large group of individuals who currently cannot be treated for their levodopa-induced dyskinesias • 3.4 to 4.2 million people worldwide live without treatment for their dyskinesia • 50% of all people living with PD and dyskinesia experience troublesome/disabling symptoms, significantly affecting daily life • 77.5% of patients with troublesome/disabling dyskinesia do not receive a dedicated anti-dyskinetic drug, relying instead on levodopa adjustments followed by surgical/device therapies Patents providing long exclusivity • Patents allowing for market exclusivity towards the mid 2040s in all large and important markets ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Among patients experiencing troublesome/disabling dyskinesia only some receive treatment – leaving most with no option 1. Thomas A, Iacono D, Luciano AL, et al. Duration of amantadine benefit on dyskinesia in severe Parkinson’s disease. J Neurol Neurosurg Psychiatry. 2004;75(1):141–143. 2. Diagnosed and treated PD population in the US and EU ≈ 2.3 million 8 Target population in the mesdopetam development program ≈ 21% of the PD population experiences troublesome/disabling dyskinesia US + EU ≈ 475 000 ≈22.5% US + EU ≈ 100 000 ≈ 77.5 % of all patients with troublesome dyskinesia are untreated US + EU ≈ 375 000
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Mesdopetam fills the gap between current levodopa based and invasive treatments 9 DBS (65 kUSD) Duodopa (75-125 kUSD 28 kGBP/yr) Produodopa (120 kUSD 31 kGBP/yr) Mesdopetam For individuals currently lacking treatment. Potential to delay invasive treatments. PD Disease severity Pharmacological treatments Invasive treatments Levodopa adjustments + other concomitant treatments ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Pirepemat IRL752 • A treatment to 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 provides significant reduction of fall rate at optimal plasma concentrations 11 • Phase IIb study in patients with a history of frequent falls • Pirepemat 300 mg, 600 mg or placebo for three months • Highly clinically meaningful and statistically significant effect (p<0.05 vs. placebo) • Adverse event profile consistent with previous studies Prespecified analyses showed that a medium plasma concentration range (exposure) of pirepemat reduced fall rate by 51.5%
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Development update Q3 12Full list of inclusion/exclusion criteria is available on https://clinicaltrials.gov/ct2/show/NCT05258071 ©2025 IRLAB Therapeutics AB (publ), All rights reserved • Strengthened development plan in place • Development of large-scale manufacturing method initiated • Preparations of a clinical study to optimize individual dosage • React–PD study results accepted for presentation at AD/PD 2026 Congress • Pan-European expert group is preparing a publication of the Phase IIb study results • KOL team appointed to advise on the further development • Patents allow for market exclusivity in all major markets extends towards mid-2040s
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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 project progress in Q3 14 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 through the Michael J. Fox Foundation • Collaboration with MSRD/Otsuka funding IRL757 through the large Phase Ib signal finding study Status • The regulatory application for the clinical trial in individuals with Parkinson's disease and apathy has been submitted to the European Medicines Agency (EMA) • Following regulatory approval of the study, the first hospitals and clinics are expected to start-up and the first patients may be recruited during the end of 2025 ©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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IRL942 project progress in Q3 16©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 completed • IRL942 shows a unique ability to activate frontal circuits and improve cognitive function in preclinical models • Potential for both symptomatic relief and disease modification in neurological indications
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IRL1117 – potential to be the first drug in a new class to treat Parkinson’s project progress in Q3 17©2025 IRLAB Therapeutics AB (publ), All rights reserved IRL1117 • A potent dopamine D1 and D2 receptor agonist with potential to replace 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 Status • Development of large-scale drug substance manufacturing (CMC work) ongoing • Preparations for the preclinical regulatory studies that are necessary for the start of Phase I are underway
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Financial highlights Q3 2025
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Financial highlights 19 • Cash position SEK 110 million. • External clinical cost continues to decrease. • Partnering costs have increased and will remain quite high as the IRL757 study advances. • Increased cost control will be maintained in the coming quarters, with a focus on the IRL757 study, retaining competence in the organization, and keeping external costs 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 20 Q1-Q3 2025 Q1-Q3 2024 Net sales, SEK 42.7m 51.8 Operating profit, SEK - 71.5m - 72.1m Earnings per share before and after dilution, SEK - 1.42 - 1.50 Cash and cash equivalents, SEK 110.1m 90.4m Cash flow from operating activities, SEK - 31.0m - 43.0m Average number of employees 31 32 Share price at the end of the period, SEK 2.92 12.70 ©2025 IRLAB Therapeutics AB (publ), All rights reserved
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Concluding remarks
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22 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 2026: Projected start of Phase III study program Next major event 2025: Completion of analyses and next steps 2026: 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 next step: IND enabling studies Preclinical 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 23 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 Roy Jonebrant, interim CFO, roy.jonebrant@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 >