Mesdopetam

Gothenburg, Sweden, October 30, 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company’s interim report for the period January-September 2024, has been published. Gothenburg, Sweden, October 30, 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today announced that the company’s interim report for the period January-September 2024, has been published. KEY HIGHLIGHTS DURING AND AFTER THE THIRD QUARTER FINANCIAL OVERVIEW OF THE SECOND QUARTER Figures in brackets = same period 2023, unless otherwise stated. PRESENTATION TO INVESTORS AND MEDIA Wednesday, October 30, 2024, at kl. 10.00 CET a presentation of the Q3 interim report will be held through a digital webcast. The presentation will be held in English, followed by a Q&A session. Access via link: https://youtube.com/live/FTY_I6oungQ CEO COMMENT My first quarter as CEO of IRLAB has been both intense and eventful. I am pleased with the progress we have made, especially on our three most advanced projects in both the clinical and regulatory areas. We have also been granted two new patents, which significantly strengthen the commercial value of our drug candidates, mesdopetam and pirepemate. In addition, I have participated in several investor meetings where I have had the opportunity to present the company and our world-leading pipeline in treatments for Parkinson’s disease. Intensive preparations for the Phase III program with mesdopetam Recent times have been characterized by intense preparations for the Phase III program with mesdopetam, which is being developed to treat levodopa-induced dyskinesias. This strengthens us in the ongoing discussions with potential partners. Several players are showing a strong interest in the project, and we are now in an exciting phase where we are evaluating different strategic ways forward for the continued development and potential commercialisation of the drug candidate. Alignment with drug regulatory authorities on the Phase III program During the past quarter, we have conducted scientific advisory meetings with the German Medicines Agency BfArM and its Portuguese counterpart INFARMED, where we discussed the design of the Phase III program for mesdopetam. The meetings provided us with valuable guidance on the key components recommended by the authorities for the program, and I can see that their recommendations are broadly in line with our proposals. This consensus strengthens our continued work, and I look forward to the upcoming interaction with the European Medicines Agency (EMA). The purpose of the strategic regulatory work is to ensure that the Phase III program and the continued development of mesdopetam are designed in a way that meets the regulatory requirements in both the US and Europe. Meta-analysis shows clinically significant effect At the end of September, IRLAB presented a meta-analysis at the international congress MDS in Philadelphia, USA. The meta-analysis, which is based on two previously conducted Phase II studies, shows that treatment with mesdopetam provides clinically significant anti-dyskinetic effects without causing impaired motor function. Further, the drug candidate reduces “OFF time”, the total time of the day when classic Parkinson’s symptoms recur. We are proud that the meta-analysis was selected for presentation at such a prestigious international conference, which is an important recognition of our work, and of the potential of mesdopetam as a treatment. Significant commercial potential of mesdopetam To provide guidance for a future launch of mesdopetam in the US and Europe, we have recently conducted in-depth market research in both regions. The results show a high willingness to pay from healthcare organizations and a significant commercial potential for mesdopetam in these regions. This is gratifying and strengthens our conviction that mesdopetam can gain a prominent position in the future treatment of Parkinson’s disease. Two new patents granted In mid-September, we received two new patents granted for mesdopetam in Europe and pirepemat in the US. The granted patents extend the already strong patent protections that we have for these drug candidates, which is very positive for the value of the projects. These successes are an acknowledgement of our innovation power and the quality of the long-term work that underpins everything we do. Patient recruitment to the Phase IIb study of pirepemat completed I would also like to highlight that we have now included all patients in our Phase IIb study of pirepemat, which is an important milestone for us. Pirepemat is being developed to improve balance and reduce the number of falls in people living with Parkinson’s disease. Blinded data for those who have undergone the study so far show that the number of falls is reduced by about one third compared to the observations during the baseline period. However, as this is a double-blind study, it is not yet possible to determine how the effect differs between the patients treated with pirepemat and those who received placebo. Therefore, it is currently not possible to draw any conclusions about the effect of pirepemat on the fall frequency. We are now looking forward to completing the study and preparing for the next phase of this project. First part of Phase I study with IRL757 completed We have successfully completed the first part of our first clinical Phase I study with the drug candidate IRL757 that is progressing towards treatment of apathy – a condition that affects millions of patients with neurodegenerative diseases worldwide. The results show that the drug candidate provides good exposure in the body and has a favorable safety profile, which bodes well for the continued clinical development. We are now continuing with the second sub-study, in which the study partici-pants receive repeated and increasing doses. At the beginning of October, we also initiated dosing in another clinical Phase I study with the drug candidate in healthy older people. With the start of the study, we received a milestone payment of USD 2.5 million from our development partner MSRD. We are very pleased to be able to complement the clinical development program of IRL757 with this study, as the majority of those affected by apathy are elderly. Strengthened position for IRLAB The third quarter of the year has now ended, and we have further strengthened our position, where the success of our projects brings us closer to new and better treatments for people with Parkinson’s disease – a disease that affects millions of people worldwide. During the quarter, I have had the opportunity to meet many of our investors and other stakeholders. These meetings have been valuable, not only to share our strategy and progress, but also to listen and understand what expectations are placed on us going forward. I appreciate the dialogue and openness shown by investors, and I look forward to continuing these conversations on our shared journey forward. We have an exciting time ahead of us where I look forward to continuing to drive, together with our strong team, the development of the company and our portfolio of pioneering drug candidates in the Parkinson’s area. For more information Kristina Torfgård, VD Phone: +46 730 60 70 99 E-mail: kristina.torfgard@irlab.se Viktor Siewertz, CFO Phone: +46 727 10 70 70 E-mail: viktor.siewertz@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 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 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. Attachments IRLAB Q3 2024 ENG

Gothenburg, 29 October 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson’s disease, today reports several advances in the preparations for Phase III with its drug candidate mesdopetam. The regulatory authorities in Germany and Portugal are positive about IRLAB’s proposed study design for the Phase III program. New market research validates the high commercial potential of mesdopetam, and a meta-analysis recently presented at the MDS scientific conference confirms the pronounced effect against levodopa-induced dyskinesias in people with Parkinson’s disease. Gothenburg, 29 October 2024 – IRLAB Therapeutics AB (Nasdaq Stockholm: IRLAB A), a company discovering and developing novel treatments for Parkinson's disease, today reports several advances in the preparations for Phase III with its drug candidate mesdopetam. The regulatory authorities in Germany and Portugal are positive about IRLAB's proposed study design for the Phase III program. New market research validates the high commercial potential of mesdopetam, and a meta-analysis recently presented at the MDS scientific conference confirms the pronounced effect against levodopa-induced dyskinesias in people with Parkinson's disease. “The recent progress in the preparation for Phase III with mesdopetam strengthens our position in the ongoing discussions with potential partners. We continue to experience strong interest from various stakeholders and are now evaluating options in the further development and potential commercialization of our unique drug candidate, mesdopetam,” says IRLAB's CEO, Kristina Torfgård. Positive feedback from regulatory authorities IRLAB has recently held scientific advisory meetings with the German regulatory authority BfArM and its Portuguese counterpart INFARMED. In the meetings, both authorities provided clear guidance on, among other things, the critical components of the Phase III program, which are essentially in line with the plans agreed upon between IRLAB and the US Food and Drug Administration (FDA). As in the dialogues with the FDA, a consensus was reached on, among other things, the patient population, the primary and secondary endpoints, that the protocol follows regulatory guidelines of at least a 3-month treatment period, essential inclusion and exclusion criteria, the dose selection (7.5 mg twice daily), the number of participants in the program, as well as details on safety evaluation and documentation requirements. The interactions with BfArM and INFARMED are part of the strategic regulatory activities, including the previously successful End-of-Phase 2 meeting with the FDA and the upcoming interaction with the European Medicines Agency (EMA). The aim is to ensure that the Phase III program and further development of mesdopetam are designed to meet the regulatory requirements in both the US and Europe. New market research confirms the commercial potential IRLAB has recently conducted in-depth market research to guide the company and its future commercial partners in positioning for a future launch of mesdopetam in the US and Europe. Structured interviews have been carried out with healthcare organization officials in both regions to better understand current treatment practices and the medical need for new treatments that can reduce levodopa-induced dyskinesias in Parkinson's disease. The results of the market research indicate a high willingness to pay for an anti-dyskinetic drug with a novel and effective mechanism of action. Thus, providing significant commercial potential for mesdopetam in both the US and Europe. It also shows that the planned design of the Phase III program aligns with the desires of the healthcare funders. New meta-analysis highlights the medical benefits of mesdopetam A meta-analysis recently presented at the International Congress of Movement Disorders (MDS) in Philadelphia, USA, shows that treatment with mesdopetam provides clinically meaningful anti-dyskinetic efficacy without causing impairment of motor function. Further, the drug candidate reduces “OFF time", the total time of the day when classic Parkinson's symptoms recur. The meta-analysis is based on two previously conducted Phase II studies with four and twelve weeks of treatment, respectively. The acknowledgment of the meta-analysis for presentation at such a prestigious international conference underscores its quality and the medical relevance of the results. For more information Kristina Torfgård, CEO Phone: +46 730 60 70 99 E-mail: kristina.torfgard@irlab.se Nicholas Waters, EVP and Head of R&D Phone: +46 730 75 77 01 E-mail: nicholas.waters@irlab.se About mesdopetam The investigational drug mesdopetam (IRL790), a dopamine D3 receptor antagonist, is being developed as a treatment for Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs). The objective is to improve the quality of life for people living with Parkinson’s and having a severe form of involuntary movements commonly occurring after chronic levodopa treatment. Around 25-40 percent of all people being treated for Parkinson’s develop LIDs, which equates to approximately 1.4-2.3 million people in the eight major markets globally (China, EU5, Japan and the US). Mesdopetam has also potential as a treatment for Parkinson’s disease Psychosis (PD-P), and other neurological conditions such as tardive dyskinesia, representing an even larger market. The Phase Ib and Phase IIa studies showed a good safety and tolerability profile as well as proof-of-concept with potential for a better anti-dyskinetic effect compared with current treatment options. A Phase IIb study, completed in 2023, showed that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect in combination with a tolerability and safety profile on par with placebo. The mesdopetam program is now undergoing preparations for Phase III. 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 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 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. Attachments IRLAB reports continued progress ahead of the mesdopetam Phase III program