Mesdopetam

GOTHENBURG, SE / ACCESS Newswire / February 25, 2026 / IRLAB Therapeutics AB (STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, today announced that the company's full-year report for the period January - December 2025, has been published. KEY HIGHLIGHTS DURING AND AFTER THE FORTH QUARTER In October, the company announced that it is advancing the fully funded study of IRL757 in Parkinson's disease and that its partner MSRD has issued a payment of USD 4 million for the study. In October, Gustaf Albèrt was appointed CFO and will assume his position on November 17. In mid‑December, the Company announced that the European Patent Office (EPO) intended to grant an additional patent for mesdopetam, covering various salt forms of the drug candidate. In December, IRLAB received regulatory and ethical approvals for a Phase Ib study of IRL757 to evaluate safety, tolerability, and signals of efficacy in patients with Parkinson's disease experiencing apathy. In January, IRLAB entered into a collaboration agreement with the Danish biotech company Biomia ApS to evaluate Biomia's drug candidates using IRLAB's research platform, the Integrative Screening Process (ISP). In mid-February, the company announced that it had received scientific advisory board confirmation on the next steps in the development of pirepemat. FINANCIAL OVERVIEW OF FORTH QUARTER Net sales: SEK 14.7m (42.8m) Operating profit: SEK -21.9m (SEK -3.0m) Earnings per share before and after dilution: SEK -0.29 (SEK -0.10) Cash and cash equivalents at the end of the period: SEK 81.9m (SEK 66.9m) Cash flow from operations: SEK -26.0m (SEK -22.6m) Share price at the end of the period: SEK 1.97 (SEK 10.15) Figures in brackets = same period 2024, unless otherwise stated. PRESENTATION TO INVESTORS AND MEDIA Wednesday, February 25, 2026, at 10.00 CEST a presentation of the full-year report 2025 will be held through a digital webcast. The presentation will be held in Swedish, followed by a Q&A session. Access via link: COMMENTS FROM THE CEO Over the past year, we have made significant progress across our research portfolio while continuously working to streamline operations and conserve resources. We have successfully advanced IRL757 in clinical development, strengthened the patent protection, clarified and confirmed the commercial potential of mesdopetam, reported promising Phase IIb results, and received strong support from leading experts for the continued development of pirepemat. In addition, we have initiated an exciting collaboration with the Danish biotech company Biomia, further expanding the opportunities to leverage our ISP research platform and our expertise in CNS disorders. Our continued focus on prioritization, resource efficiency, and strategic partnerships provides a strong foundation for ongoing innovation and long-term value creation. Progress with IRL757 - the approval confirms the quality of our work We have made significant progress with the drug candidate IRL757. Over the past year, we completed and compiled the documentation from two Phase I studies in healthy volunteers. In December, we received regulatory and ethics approval in Europe to initiate the Phase Ib LIFT-PD study in people with Parkinson's disease and apathy - an important step forward in the clinical development of the candidate. The study is now underway; all clinical trial sites in the LIFT-PD study are now activated, patient recruitment and screening are ongoing. Through our close and productive collaboration with MSRD/Otsuka, we continue to advance the development of IRL757, and the project is funded through the Phase Ib study and its evaluation. The development of IRL757 is particularly meaningful given that there are currently no established drug treatments for apathy. The unmet medical need is substantial, and the opportunity to ultimately improve the quality of life for people living with Parkinson's disease and apathy is a strong driving force across the organization. Strengthened patent protection and significant market potential for mesdopetam During the year, we further strengthened the intellectual property protection for mesdopetam through newly granted patents in the United States and China, among other regions. These approvals complement our existing patent portfolio and support long-term market exclusivity across key strategic markets well into the 2040s. For us, this represents an important milestone that further enhances the project's commercial potential. We have also conducted market research to deepen our understanding of the unmet medical need and the target patient population for mesdopetam. The most recent study included physicians experienced in treating patients with Parkinson's disease and levodopa-induced dyskinesias (LIDs). The findings confirm our view of the landscape - that the need for new and improved treatments for LIDs remains very high. Physicians responsible for very large patient populations expressed strong interest in mesdopetam and were particularly positive about the candidate's clinical profile, which clearly distinguishes it from existing treatment approaches. They indicated that, if available, they would prescribe mesdopetam to a substantial proportion of their patients and estimate that it could be used in approximately 75% of patients with quality-of-life-impacting LIDs who currently lack adequate treatment options. The documented insight strengthens our position in discussions with potential partners and supports favorable conditions for advancing mesdopetam to the market as an effective treatment for patients with LIDs. Formulärets överkantFormulärets nederkant. Strong potential and support for pirepemat's clinical results In early 2025, we reported promising results from the Phase IIb REACT-PD study, which established the therapeutic window for pirepemat. This marks an important milestone and has generated valuable insights for dose optimization and individualized treatment strategies. The focus going forward is on further refining and optimizing dosing in preparation for a future Phase III program. The Phase IIb results were discussed in December with leading international experts in the field. Their feedback has been highly encouraging and aligned with our assessment of pirepemat's potential. They have also expressed strong support for our continued development strategy, further reinforcing confidence in the next steps of the program. In parallel, we consider it important to actively share our clinical progress with both the scientific community and broader stakeholder audiences. We look forward to presenting the results at the international AD/PD conference in March 2026 and in scientific journals. Focus on priorities, partnerships, and long-term value creation Thanks to the strong support from our shareholders, both through the loan provided early in the year by major shareholders and the subsequent rights issue conducted over the summer, we were able to strengthen our financial position. In line with previously communicated priorities, the company has now implemented a voluntary reduction in working hours in order to adjust the cost base and ensure efficient resource allocation. The measure strengthens the conditions for focusing on strategically important areas for continued development, including efforts to enable future collaborations and out-licensing, with innovative projects as a foundation for long-term value creation. In early 2026, we initiated a collaboration with the Danish biotech company Biomia to evaluate their drug candidates using IRLAB's research platform. This partnership allows us to leverage our expertise in drug discovery for CNS disorders. IRLAB already has several drug candidates in Parkinson's disease and other CNS indications, and this collaboration represents a natural step in further developing and expanding our work. We are seeing increasing interest from more companies in collaborations, both at the early and later stages of development, but the process of reaching licensing agreements or other collaborations is taking longer than previously anticipated. We remain committed to our goal of developing new, unique first-in-class candidates that can provide effective treatment alternatives for Parkinson's disease and improve the lives of individuals living with the condition worldwide. I look forward to another eventful year with great confidence. Together with our dedicated team, the Board, and our shareholders, we will continue to build long-term value and take the next steps on our shared journey. 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 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 . Attachments IRLAB Year End Report 2025 Jan Dec ENG FINAL SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire