Mesdopetam

GOTHENBURG, SE / ACCESS Newswire / May 6, 2026 / IRLAB Therapeutics AB (STO:IRLAB-A)(FRA:6IRA), a company discovering and developing novel treatments for Parkinson's disease, today announced that the interim report for the period January-March 2026, has been published. KEY HIGHLIGHTS DURING AND AFTER THE FIRST QUARTER 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. In February, the Company announced that it had secured a milestone payment of USD 3 million following the dosing of the first patient in the Phase Ib study, LIFT-PD, of IRL757 in Parkinson's disease. In March, the Company presented clinical and preclinical data at AD/PD™ 2026-the 20th International Conference on Alzheimer's and Parkinson's Diseases. In April, the nomination committee proposed the election of Jan Fredrik Backman as new Vice Chairperson and James Gamgort as new Board member at the Annual General Meeting in 2026 and in addition re-election of Chairperson Carola Lemne and Board members Gunnar Olsson, Rein Piir and Veronica Wallin. Christer Nordstedt has declined re-election. In May, the Board of Directors resolved on a rights issue of approximately SEK 68 million, consisting of Class A shares, with an overallotment issue of approximately SEK 33.8 million, subject to approval by the extraordinary general meeting. In connection with the share issue, the Company announced that the the term for SEK 18.5 million of the outstanding loan of SEK 23.7 million from Fenja Capital has been extended to 30 November 2027. The remaining SEK 5.2 million is to be repaid in connection with the completion of the rights issue. In May, the Board of Directors resolved to convene an Extraordinary General Meeting on 5 June 2026 to approve the proposed share issue, resolve on an amendment to the Articles of Association, and elect new members to the Board of Directors. FINANCIAL OVERVIEW OF FIRST QUARTER Net sales: SEK 39.4m (4.4m) Operating profit: SEK 10.7m (SEK -28.6m) Earnings per share before and after dilution: SEK 0.11 (SEK -0.65) Cash and cash equivalents at the end of the period: SEK 50,8m (SEK 88.6m) Cash flow from operations: SEK -28.7m (SEK 12.3m) Share price at the end of the period: SEK 1.50 (SEK 7.94) Figures in brackets = same period 2025, unless otherwise stated. PRESENTATION TO INVESTORS AND MEDIA Wednesday, May 6, 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: COMMENTS FROM THE CEO During the first quarter, we advanced IRL757 into Phase Ib, secured a milestone payment of USD 3 million, progressed IRL1177 toward clinical stage, and took measures to reduce our cost base. Supplementary market analyses confirmed the commercial potential of mesdopetam, and internationally leading experts expressed support for the continued development of pirepemat - strengthening our position in ongoing partner discussions. Following the end of the reporting period, the Board of Directors resolved on a capital raise, subject to approval at an Extraordinary General Meeting. With subscription commitments and indications of interest covering approximately 91 percent of the offering, it can be completed without external underwriting guarantees - which, in today's challenging market environment, we view as a strong vote of confidence in the company. Overall, our focus on prioritization, capital efficiency, and strategic partnerships has built a solid foundation for continued innovation and long-term value creation. First patient study with IRL757 initiated and milestone payment secured Following two successful Phase I studies, we have now entered the next development stage for IRL757 with the initiation of the Phase Ib study LIFT‑PD, conducted in Europe. The study targets patients with Parkinson's disease and apathy -an area with no established treatment options. Recruitment is progressing according to plan, with the first patients enrolled in early 2026. This represents a significant milestone for us and a clear validation of the progress made in the development of IRL757. In connection with the first dosing, we also secured a milestone payment of USD 3 million, further strengthening our financial position. We expect to report initial results from the LIFT‑PD study in mid‑2027. The development of IRL757 is fully funded through proof of concept via our partnership with MSRD/Otsuka, which also contributes extensive scientific and clinical expertise. Importantly, IRLAB retains full ownership of all rights to the project and has the option at a later stage to enter into a licensing agreement with MSRD or a third party ahead of the next development phase and potential commercialization. Significant market potential for mesdopetam supported by strong patent protection During the quarter, we completed our in‑depth market analyses through dialogues with internationally renowned Parkinson's disease specialists. These discussions confirm a substantial unmet medical need for new treatment options for patients with Parkinson's disease and levodopa‑induced dyskinesias (LIDs). Strong clinical interest in mesdopetam was identified, particularly due to its clearly differentiated profile. Assessments indicate that the drug candidate could be used by up to approximately 75 percent of patients suffering from quality‑of‑life‑impacting LIDs who currently lack satisfactory treatment options. With strong intellectual property protection, an increasingly robust market foundation, and a demonstrated willingness to pay, we are well positioned to advance our ongoing partner discussions. Strong interest in pirepemat among international experts The Phase IIb REACT‑PD study has provided us with important and valuable insights into pirepemat, particularly regarding the drug candidate's therapeutic window. Although the study did not meet its primary efficacy endpoint, the results have established a solid foundation for dose optimization and increased individualization in future studies. To me, this confirms the value of a rigorous, long‑term, and learning‑oriented clinical development approach. The feedback received in late 2025 from leading international experts has been very positive, strengthening our confidence in the project's potential - there are currently no established treatments for falls and fall‑related injuries in patients with Parkinson's disease. This strong interest was further confirmed at the international AD/PD conference in March 2026, where the REACT‑PD results generated significant engagement and led to both continued and new discussions. We plan to make a decision on the next steps in the development of pirepemat towards the end of the second quarter of 2026. IRL1117 - Improving quality of life for patients with Parkinson's disease With its unique mechanism of action, IRL1117 has the potential to transform everyday life for patients with Parkinson's disease across all stages of the condition. The objective is to develop a treatment with improved adherence and, over time, to replace levodopa as first‑line therapy -without the typical fluctuations and motor complications associated with current treatment. During the period, we continued to build value in the project through additional preclinical studies in preparation for a future Phase I clinical trial application, while scale‑up of active pharmaceutical ingredient production is now underway. Focus and priorities for 2026 Our priorities for 2026 are clear: to enter into at least one partnership agreement that strengthens revenues and realizes value within the portfolio; to ensure that IRL757 progresses according to plan toward data read‑out in mid‑2027; to prepare the next clinical study and make a decision regarding pirepemat during Q2; and to further advance IRL1117 with the objective of making the project ready for Phase I. After the end of the reporting period, the Board of Directors resolved to carry out a rights issue of approximately SEK 68 million, with the possibility of an additional approximately SEK 34 million through an overallotment issue, for a total of SEK 102 million - both subject to approval at the upcoming Extraordinary General Meeting. Subscription commitments from both existing shareholders and new professional investors, as well as subscription intentions from the Board and management, cover approximately 91 percent of the issue. This strong level of commitment is a clear testament to confidence in the company and enables the capital raise to be completed without the customary external underwriting guarantees, despite today's challenging market environment, thereby keeping transaction costs down. In addition, we are extending the loan financing from Fenja Capital to November 2027. In the event of full subscription for both issues, the company is funded into the fourth quarter of 2027, beyond the planned readout of the LIFT-PD study with IRL757, giving us the freedom of action we need to achieve our goal of signing at least one revenue-generating partnership agreement during the current year. During the coming period, the number of employees and operating costs are expected to decrease further through natural attrition. Discussions with potential partners are well advanced, and active development work across our projects continues. Reaching definitive agreements has taken longer than planned, but the progress made over the past two quarters puts us in a stronger position as we approach the strategically important steps ahead. I look forward to continuing the development of both the company and the groundbreaking projects within our research portfolio. With the right focus, discipline, and execution capability, I am confident that, based on our research portfolio, we are well positioned to generate tangible and long‑term value- for patients, partners, and shareholders. Finally, I would like to express my sincere appreciation to our shareholders for your continued trust, and to our employees for your commitment, expertise, and tireless efforts. 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 Q1 2026 ENG Final SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire