IRLAB Therapeutics (STO:IRLAB-A)(FRA:6IRA) Gothenburg, Sweden, February 12, 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 full-year report for the period January-December 2024, has been published.
KEY HIGHLIGHTS DURING AND AFTER THE FOURTH QUARTER
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In October, the company presented the company data from a meta-analysis of two studies evaluating the efficacy of mesdopetam at the International Congress of Parkinson's Disease and Movement Disorders (MDS), in Philadelphia, USA.
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In October, the company received positive data from the first part of the Phase I study with the drug candidate IRL757.
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In October, IRLAB receives milestone payment of USD 2.5 million in conjunction with first dosing in a PhaseI study with IRL757 in healthy older adults.
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In October, the company reported continued progress in the preparations of the mesdopetam Phase III program including positive feedback from the regulatory authorities in Portugal and Germany, as well as payor research confirming significant market potential for mesdopetam in both the US and Europe
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In mid-January, the company announced that last patient had completed the full treatment period in the Phase IIb study with pirepemat.
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In January the company received a waiver from the EMA regarding paediatric studies with mesdopetam in Parkinson's Disease.
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In end-January, the company reported positive topline results from Phase I study with IRL757 in healthy older adults.
FINANCIAL OVERVIEW OF 2024
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Net sales: SEK 94.6m (SEK 5.7m)
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Operating profit: SEK -75.1m (SEK -180.8m)
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Earnings per share before and after dilution: SEK -1.60 (SEK -3.43)
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Cash and cash equivalents at the end of the period: SEK 66.9m (SEK 111.3m)
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Cash flow from operations: SEK -65.6m (SEK -164.8m)
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Share price at the end of the period: SEK 10.75 (SEK 7.50)
Figures in brackets = same period 2023, unless otherwise stated.
PRESENTATION TO INVESTORS AND MEDIA
Wednesday, February 12, 2025, at kl. 10.00 CET a presentation of the full-year 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=udzoDVqBbcM
CEO COMMENT
It is with great pleasure that I summarize 2024 - a year in which IRLAB has continued to make significant progress in research, development and strategic partnerships. Through dedicated and purposeful efforts, we have moved closer to our goal of improving the lives of people living with Parkinson's disease and other neurodegenerative conditions.
Pioneering research, innovation and collaboration permeate IRLAB
When I took over the role as CEO of IRLAB in August 2024, I was met by a company with great visions and a strong commitment. For me personally, it has been an intense and eventful period, filled with both challenges and important progress. I am proud to be part of the IRLAB team and have been deeply inspired by the unique combination of pioneering research, innovation and collaboration that permeates the entire company.
Preparations for Phase III and significant market potential for mesdopetam
We have made great progress in the preparation of the upcoming Phase III program with mesdopetam, which is being developed to treat levodopa-induced dyskinesias. Through our dialogues with the FDA in connection with the End-of-Phase 2 meeting and the interactions with the regulatory authorities in Germany and Portugal, we have reached a consensus on the study design, a crucial piece of the puzzle for the pivotal studies. At the same time, we have worked to enhance the value of the mesdopetam project through analysis of the market and the healthcare payers' willingness to reimburse the treatment. These analyzes indicate that there is significant market potential for mesdopetam both in the US and Europe. The preparations for Phase III and the substantial market potential for mesdopetam strengthen our position in the ongoing discussions with potential license partners.
The Phase IIb study of pirepemat provides valuable insights for further development
Many individuals with Parkinson's disease suffer from severe balance problems, often leading to frequent falls. In addition to significantly impacting quality of life, this can result in serious complications, including fall-related injuries and increased mortality. Currently, there are no approved treatments that reduce the risk of falling. The ongoing Phase IIb study React-PD, which evaluates the effect of pirepemat on fall rates in Parkinson's patients, has provided us with invaluable insights into these challenges. With support from regulatory authorities, we were able to optimize the study design, enabling the completion of patient recruitment last year. In early 2025, we reached a key milestone when the last patient had completed the full treatment period. We are now looking forward to the study results, expected in the first quarter of this year.
Collaborations secure funding for drug candidate IRL757
Our third candidate in clinical phase, IRL757, which is being developed to treat apathy, has made significant progress. We are proud to have initiated and completed two Phase I studies during the year, an impressive achievement given the extensive preparations and regulatory approvals required. With the promising results, we now look forward to continuing the clinical development of IRL757. During the year, we entered into an important collaboration agreement with MSRD/Otsuka, ensuring full funding for development up to Proof-of-Concept. This partnership not only provides significant financial security but is also a strong validation of our research, reinforcing our position as a leading innovator in the treatment of apathy in neurological disorders.
Research grants, milestone payments and strengthened patent portfolio.
During the past year, we were provided with additional financial resources through grants from the Michael J. Fox Foundation, milestone payments from MSRD/Otsuka and a strategic use of the remaining part of a loan facility that was secured already in 2023. Additionally, we have received two new patents for mesdopetam and pirepemat, which further extend exclusivity periods and thus strengthens their commercial value.
A successful year with a focus on the future
Our pipeline is stronger than ever. We have presented our progress at several international conferences and investor meetings, where interest in our projects has been remarkably high. This reinforces my conviction that our drug candidates have the potential to become first-in-class treatments that can transform the lives of millions of people worldwide, along with their loved ones.
With the progress we have achieved so far and the exciting opportunities ahead, I look forward with confidence to leading IRLAB further into the next phase of our growth journey. I would like to extend my sincere gratitude to all employees for the outstanding work that has contributed to this year's success in our project portfolio. A heartfelt thank you also goes to our shareholders for your continued trust - your support enables us to pursue our vision of developing groundbreaking treatments for Parkinson's disease and other neurodegenerative disorders.
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 Q4 ENG 2025 02 12
SOURCE: IRLAB Therapeutics
