Mesdopetam

GOTHENBURG, SE / ACCESS Newswire / August 26, 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-June 2026, has been published. KEY HIGHLIGHTS DURING AND AFTER THE SECOND QUARTER 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 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. In June, the company announced that it will present an integrated analysis of clinical data for mesdopetam at the international conference StanCon 2026. The analysis confirms robust efficacy results from the Phase II clinical studies. In June, the company announced the outcome of the rights issue. With a subscription rate of approximately 112.6%, the company raised approximately SEK 68 million before deduction of transaction costs. As the rights issue was oversubscribed, the company received an additional approximately SEK 8.6 million through an over-allotment issue, before deduction of issue-related costs. Consequently, the company raised a total of approximately SEK 76.5 million through the rights issue and the over-allotment issue, before deduction of issue-related costs. In June, the company published the communiqué from the Annual General Meeting. All proposed resolutions were approved by the meeting. Christer Nordstedt stepped down from the Board of Directors in connection with the AGM. Following the meeting, the Board consists of Carola Lemne (Chairperson), Jan-Fredrik Backman (Vice Chairperson), James Gamgort, Gunnar Olsson, Rein Piir, and Veronica Wallin. In July, the Company announced that the registered number of shares and votes in IRLAB Therapeutics AB had increased as a result of the rights issue of Class A shares. As of 31 July 2026, the total number of shares in IRLAB amounted to 146,461,921, of which 146,382,145 were Class A ordinary shares and 79,776 were Class B ordinary shares, each carrying one (1) vote. In August, the Company announced that the World Health Organization (WHO) had assigned the drug candidate IRL757, which is being developed as a potential first-in-class treatment for apathy, the International Nonproprietary Name (INN) linepemat. FINANCIAL OVERVIEW OF SECOND QUARTER Net sales: SEK 6.4m (19.5m) Operating profit: SEK -16.7m (SEK -25.7m) Earnings per share before and after dilution: SEK -0.23 (SEK -0.62) Cash and cash equivalents at the end of the period: SEK 34.2m (SEK 53.6m) Cash flow from operations: SEK -13.4m (SEK -42.6m) Share price at the end of the period: SEK 1.24 (SEK 3.92) 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: 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 pro 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 . Attachments IRLAB Q2 2026 ENG Final SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire

ANNOUNCEMENT FOR EUROPEAN MEDICAL & PHARMACEUTICAL TRADE MEDIA AND EUROPEAN FINANCIAL MEDIA ONLY GOTHENBURG, SE / ACCESS Newswire / August 19, 2026 / IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA), a company focused on discovering and developing new treatments for Parkinson's disease, today announced that the World Health Organization (WHO) has assigned the company's drug candidate IRL757 the unique generic name linepemat. The drug candidate is being developed as a potential first-in-class treatment for apathy associated with Parkinson's disease and other neurological conditions and is currently being evaluated in the Phase Ib LIFT-PD study, which is fully funded by IRLAB's collaborator, Otsuka Pharmaceutical (Otsuka). The assignment of an International Nonproprietary Name (INN) confirms that the compound has a unique chemical identity and establishes an internationally recognized name for use by researchers and healthcare professionals worldwide. The assignment also means that the company will henceforth refer to the drug candidate as linepemat in its communications. Linepemat is being developed as a potential first-in-class treatment for apathy associated with Parkinson's disease and other neurological conditions. Apathy is characterized by indifference, resignation and a lack of response to what is happening in the outside world. The condition often leads to significant disability affecting a substantial proportion of people living with Parkinson's disease and other neurodegenerative diseases. Currently, there are no drugs on the market to treat apathy. The LIFT-PD clinical study is being conducted under IRLAB's leadership and is fully funded by Otsuka. IRLAB retains full ownership of linepemat. Otsuka has the opportunity to elect to expand the collaboration upon the occurrence of certain triggering events, subject to negotiations of a new agreement. The first results from the LIFT-PD study are expected to be reported in mid-2027. "The assignment of the INN name linepemat represents an important milestone in the development of the drug candidate and a clear recognition of the compound's unique properties. Apathy is one of the most debilitating symptoms of Parkinson's disease, as well as several other neurological and psychiatric disorders. With linepemat, we aim to address a significant unmet medical need for which no approved treatment currently exists, and we look forward to presenting the first results from the LIFT-PD study in 2027," says Kristina Torfgård, CEO of IRLAB 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 linepemat (IRL757) The drug candidate linepemat (IRL757) is being developed as a treatment for apathy in Parkinson's disease and other neurological conditions. Apathy, a widespread and debilitating issue, affects over 20 million people in the U.S. and Europe alone without a currently available treatment. The prevalence is high, occurring in 1.1-4 million people (20-70 percent) being treated with Parkinson's in the eight major markets (China, EU5, Japan, and the US), and in 4.9-6.7 million people (43-59 percent) being treated for Alzheimer's disease in the ten major markets (Canada, China, EU5, Japan, South Korea, and the US). Linepemat has the potential to become the first treatment for apathy. The efficacy of linepemat is thought to be linked to its unique ability to reverse disruption in cortical to sub-cortical nerve signalling, a key factor believed to contribute to apathy in neurological disorders. Linepemat, currently in Phase Ib, is being developed for the treatment of apathy in neurodegenerative disorders. 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’s Drug Candidate IRL757 Receives the Generic Name linepemat from the WHO SOURCE: IRLAB Therapeutics View the original press release on ACCESS Newswire