GOTHENBURG, SE / ACCESS Newswire / May 7, 2025 / 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-March 2025, has been published.
KEY HIGHLIGHTS DURING AND AFTER THE FIRST QUARTER
In mid-January, the company announced that the last patient had completed the full treatment period in the Phase IIb study with pirepemat.
In January, the company was granted a waiver by the EMA regarding pediatric studies with mesdopetam for Parkinson's disease.
At the end of January, the company reported positive topline results from the Phase I study with IRL757 in healthy elderly subjects.
In February, the company's loan financing was refinanced and expanded.
Also in February, the company received positive feedback from the EMA confirming alignment with the FDA regarding the Phase III program for mesdopetam.
In March, topline results from the Phase IIb study with pirepemat were first reported, followed by additional positive efficacy data from the same study.
Preclinical data for mesdopetam were also published in March in the journal European Journal of Neuroscience.
At the end of March, the company announced the launch of a study with IRL757 in Parkinson's disease, fully funded by its development partner MSRD.
FINANCIAL OVERVIEW OF 2024
Net sales: SEK 4.4m (-)
Operating profit: SEK -28.6m (SEK -37.6m)
Earnings per share before and after dilution: SEK -0.65 (SEK -0.75)
Cash and cash equivalents at the end of the period: SEK 88.6m (SEK 73.1m)
Cash flow from operations: SEK 6.3m (SEK -38.2m)
Share price at the end of the period: SEK 7.94 (SEK 15.6)
Figures in brackets = same period 2024, unless otherwise stated.
PRESENTATION TO INVESTORS AND MEDIA
Wednesday, May 7, 2025, at 11.30 CEST a presentation of the 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://www.youtube.com/watch?v=RWNlkYDnHWg
COMMENTS FROM THE CEO
The first quarter of 2025 has been one of our most dynamic to date, marked by significant regulatory progress, promising clinical results, and the deepening of strategically important partnerships, all collectively strengthening our position. Following an in-depth analysis of the topline data for pirepemat presented during the quarter, we can confidently affirm that all of our development programs continue to make evident progress and bring us closer to our goal - to provide new, effective treatments for people living with Parkinson's disease.
Regulatory progress paves the way for the next stage in the development of mesdopetam
In January, the EMA granted us a waiver from the requirement to conduct pediatric studies with mesdopetam in Parkinson's disease. This decision is in line with the previous approval from the FDA. It means that we can now fully focus our resources and energy on developing mesdopetam for the treatment of levodopa- induced dyskinesias (LIDs) in adults- an area with a significant unmet medical need.
In early 2025, we also received positive feedback from the EMA, confirming alignment with the FDA regarding the Phase III program for mesdopetam. Based on our previously successful End-of-Phase 2 meeting with the FDA and the positive dialogue with the EMA, we are now preparing for registration-enabling Phase III studies of this drug candidate.
These regulatory advances reinforce our conviction that we are on the right track and add weight to our ongoing discussions with potential partners. We look forward to offering a treatment that has the potential to address one of the most pressing needs in the Parkinson's field - to effectively treat LIDs and thereby improve the quality of life for affected patients worldwide.
Promising results with pirepemat - one step closer to a new treatment
In March, we presented topline results from the Phase IIb study (REACT-PD) of pirepemat in patients with Parkinson's disease. The initial analysis showed that treatment with 600 mg of pirepemat daily reduced the fall rate by 42 percent-a clear effect, even though the outcome did not reach statistical significance in the overall population.
However, in the in-depth analyses of the efficacy data, we could clearly see that patients with medium plasma concentrations of pirepemat showed a fall reduction of as much as 51.5 percent after three months of treatment. This outcome is both clinically meaningful and statistically significant. These insights are highly valuable and provide essential guidance for optimizing dosing and study design in the next development phase. At the same time, the results strengthen our belief in pirepemat as a potential treatment to reduce fall risk and improve the quality of life for patients with Parkinson's.
I am proud of our team's work and look forward to continuing the development of pirepemat, which has the potential to become the world's first treatment targeting the severe balance problems - resulting in falls and injuries - that affect people with Parkinson's disease.
Strategic partnerships and positive results support the development of IRL757
We have made significant progress in developing our drug candidate IRL757, with two completed clinical Phase I studies. The most recent study, conducted in healthy elderly individuals, showed positive results earlier this year. The study demonstrated that IRL757 is well absorbed, provides good systemic exposure, and has a favorable safety profile. These results represent an important milestone for us, as they form the basis for the next development step - initiating a clinical study in patients with Parkinson's disease who suffer from apathy. We expect to begin recruiting the first patients during the second half of 2025.
I would also like to highlight our strong partnership with MSRD/Otsuka, which provides full funding for the development of IRL757 through proof-of-concept (PoC). Combined with our collaboration with the Michael J. Fox Foundation for Parkinson's Research (MJFF), this not only ensures critical financial support but also serves as a strong validation of our scientific platform and our position as a leading innovator in treating apathy in neurological disorders.
We now look forward with confidence to continuing the development of IRL757, with the goal of offering a treatment for apathy where the medical need for effective therapies is very high.
New insights into drug candidates with the potential to become first-in-class treatments
During the first quarter, a scientific article on mesdopetam was published in the medical journal European Journal of Neuroscience. The article is based on preclinical studies and provides new insights into the mechanisms behind levodopa-induced dyskinesia. The data provide f fresh perspectives into the system- level mechanisms behind the antidyskinetic effect of mesdopetam and suggest potential additional benefits in the treatment of Parkinson's related psychosis (PD-P). Given resources, clinical studies in psychosis could broaden and strengthen the compound's future commercial potential.
In April, we participated in the international conference on Alzheimer's and Parkinson's diseases (ADPD) in Vienna, where we presented progress on pirepemat and IRL757. Both drug candidates are so-called "cortical enhancers," acting by directly strengthening neural signaling in the cerebral cortex. Cortical dysfunction is a key factor in neurodegenerative diseases, including Alzheimer's and Parkinson's. The presentation on pirepemat, featuring new and compelling data on fall frequency, attracted significant interest and was well received by key opinion leaders and leading experts in the field.
We view participation in international congresses and publications in scientific journals as important steps forward, as they reinforce the scientific foundation for our continued development of these drug candidates. It is gratifying to see our research efforts being recognized and continuing to build value.
Enhanced opportunities, priorities for value creation at IRLAB
We have taken several important actions to ensure financial sustainability during this critical phase. We have extended the maturity of the existing loan from Fenja Capital, with the possibility of further expanding it under certain conditions. In addition, we have secured new loans from some of our largest shareholders. In the short term, these measures strengthen our financial position and provide the resources needed to focus on reaching several potentially value-creating milestones in the near future.
We have a strong and broad project portfolio with five unique first-in-class candidates. Our main focus is currently on establishing partnerships for mesdopetam and pirepemat, as well as advancing IRL757 through to PoC. For the benefit of these prioritized projects, along with IRL1117, we will slow the development pace of IRL942 and not proceed with toxicology studies at CROs, which means that we will not be ready for Phase I during 2025. At the same time, we are reviewing our costs to ensure we can focus our resources on the activities most critical to our continued development.
During the quarter, I had the pleasure of meeting many of our investors and other stakeholders. These meetings have been very rewarding-not only as an opportunity to share our progress and strategy but also to gain valuable insights, understand expectations, and gain experience and commitment for the future of IRLAB. I appreciate the open and constructive dialogue and look forward to continuing this journey together with our committed owners and our competent, dedicated team.
Thank you for your continued trust!
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 Q1 FINAL EN
SOURCE: IRLAB Therapeutics
View the original press release on ACCESS Newswire:
https://www.accessnewswire.com/newsroom/en/healthcare-and-pharmaceutical/irlab-publishes-interim-report-for-the-period-january-march-2025-1024603
