Gothenburg, Sweden, August 26, 2026 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the interim report for the period January-June 2026, has been published.
KEY HIGHLIGHTS DURING AND AFTER THE SECOND QUARTER
FINANCIAL OVERVIEW OF SECOND QUARTER
Figures in brackets = same period 2025, unless otherwise stated.
PRESENTATION TO INVESTORS AND MEDIA
Wednesday, August 26, 2026, at 10.00 CEST a presentation of the interim report 2026 will be held through a digital webcast. The presentation will be held in Swedish, followed by a Q&A session.
Access via link: https://youtube.com/live/OLKumPEvUq8
COMMENTS FROM THE CEO
During the period, IRLAB took several important steps forward: the drug candidate IRL757 was assigned the international nonproprietary name (INN) linepemat, an integrated analysis confirmed mesdopetam’s efficacy profile ahead of Phase III, and a successful capital raise strengthened the company’s financial position. With a strengthened cash position, the company is now aiming to bring the ongoing partner discussions to a conclusion during the year and deliver results from the Phase Ib study LIFT-PD in mid-2027.
Linepemat (IRL757) – advancing toward the next milestone
During the summer, we reached an important milestone when the World Health Organization (WHO) assigned IRL757 the generic name linepemat. The assignment of an internationally recognized nonproprietary name to a drug candidate confirms that the substance has a unique chemical identity and represents a distinct pharmaceutical compound. This means that the substance name is recognized worldwide and can be used by researchers, healthcare professionals, and in future pharmaceutical products. Going forward, we will therefore use the name linepemat in our external communications.
We continue to make good progress in LIFT-PD, our Phase Ib study of linepemat in people with Parkinson’s disease and apathy. Recruitment is progressing, and we expect to present the first study results in mid-2027.
Apathy is a serious and often overlooked symptom for which there are currently no approved treatment options. To me, linepemat is one of the company’s most attractive drug candidates, as it addresses an area with a very high unmet medical need.
Our collaboration with Otsuka secures funding for the development program through the LIFT-PD proof-of-concept study while also providing access to extensive scientific, clinical, and commercial expertise. Equally important, IRLAB retains all rights to the program, giving us significant strategic flexibility as we evaluate the next stages of development and future commercialization opportunities. Under the collaboration agreement, Otsuka has the opportunity to elect to expand the collaboration on linepemat following the completion of the LIFT-PD study.
Integrated analysis confirms mesdopetam’s robust efficacy results
Another important event during the period was the presentation of an integrated analysis of clinical data for mesdopetam, our lead drug candidate for the treatment of levodopa-induced dyskinesias (LIDs), at StanCon 2026 – International Conference on Bayesian Inference and Probabilistic Programming.
The analysis is based on pooled data from our randomized, placebo-controlled Phase II studies and includes evaluations and comparisons of a large number of Bayesian statistical models. Although the numerical estimates of mesdopetam’s anti-dyskinetic effects vary across models, the overall conclusion is unequivocal: the analysis confirms mesdopetam’s clinically meaningful and favorable efficacy profile, as well as its anti-dyskinetic efficacy. For us, this represents important validation of the strength of the clinical data package for mesdopetam. The findings are valuable in preparing the program for Phase III, the final stage of clinical development, and further strengthen our position in ongoing partnering discussions regarding the program’s continued development and commercialization.
During the quarter, we conducted an analysis of market access and pricing in Europe to reassess previous assumptions in light of evolving requirements for the valuation and reimbursement of new medicines, as well as global pricing dynamics. The analysis indicates that mesdopetam has the potential to achieve attractive and similarly high net prices in both Europe and the United States, with no significant risk associated with international reference pricing.
Strengthened foundation for the continued development of pirepemat
The positive feedback from leading international experts and the strong interest shown at the AD/PD 2026 scientific congress have reinforced our confidence in pirepemat’s potential to prevent falls in people living with Parkinson’s disease, an area where no established treatments currently exist. The insights generated from the REACT-PD clinical study provide a stronger foundation for the program’s continued development. We are now focused on designing the next clinical study and defining the regulatory strategy needed to support further progress. In parallel, work continues to advance the large-scale manufacturing process for the active pharmaceutical ingredient. To finance the next stage of development, a partnership or licensing agreement is required to support the program’s continued development and commercialization.
IRL1117 – advancing the future of Parkinson's disease treatment
IRL1117 has the potential to improve the standard treatment of Parkinson’s disease. Based on the drug candidate’s unique properties and mechanism of action, the objective is to develop a therapy with improved treatment adherence and, over time, provide an alternative to today’s standard levodopa-based treatment, without the typical fluctuations and motor complications that often develop during long-term levodopa therapy.
During the period, we continued to strengthen the program through preclinical studies in preparation for a future application to initiate Phase I clinical trials. In parallel, the scale-up of active pharmaceutical ingredient (API) manufacturing is ongoing, representing an important step in preparing for the next phase of development.
Strengthened financial position creates new opportunities
Thanks to the rights issue and overallotment issue completed during the second quarter, we have strengthened our financial position, enhancing our ability to bring the ongoing partner discussions to a conclusion during the year.
At the same time, we have created additional flexibility to further increase the attractiveness of our drug development projects and reduce our reliance on debt financing. The capital infusion enables us to fund operations beyond the readout of the Phase IIb LIFT-PD study with linepemat (IRL757) in 2027, a key milestone in the development of the drug candidate for the treatment of apathy. It also allows us to advance IRL1117 toward Phase I, further strengthening the attractiveness of our project portfolio.
Well positioned for upcoming milestones
During the period, the Board of Directors was strengthened through the appointments of Janne Backman and James Gamgort. Their extensive experience in international business development and commercialization will be highly valuable to IRLAB as we focus on partnerships, continued clinical development, and the creation of long-term value.
I would like to extend my sincere thanks to both existing and new shareholders for your trust and support, to the Board of Directors for its commitment, and to all IRLAB employees for their hard work and dedication. I would also like to express my gratitude to the patients and caregivers participating in our studies. Your trust and involvement make our work possible.
With the clear priorities we established at the beginning of 2026 and a strengthened financial position, I look forward to leading the company toward upcoming milestones and working purposefully to realize the potential within our project portfolio. With several important value-driving milestones ahead, I am confident about the company's continued development.
For more information
Kristina Torfgård, CEO
Phone: +46 730 60 70 99
E-mail: kristina.torfgard@irlab.se
Gustaf Albèrt, CFO
Phone: +46 709 168 302
E-mail: gustaf.albert@irlab.se
This information is information that IRLAB Therapeutics is obliged to make public pursuant to the Securities Markets Act. The information was submitted for publication, through the agency of the contact persons set out above, at 2026-08-26 07:00 CEST.
About IRLAB
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 fall frequency in Parkinson's disease. IRL757, a compound being developed for the treatment of apathy in neurodegenerative disorders, is in Phase Ib. In addition, the company is 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). For more information, please visit www.irlab.se.