IRLAB Therapeutics

KEY HIGHLIGHTS DURING AND AFTER THE THIRD QUARTER

• In July, the company announced that the Phase IIb study of pirepemat, React-PD, could proceed as planned after positive opinion from external safety committee (DSMB).
• In September, IRLAB was granted an additional patent for drug candidate mesdopetam that expands its patent protection in Europe.
• In September, the company announced that that an additional patent had been granted for its drug candidate pirepemat expanding the patent protection in the US.
• 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.
• In October, the last patient was enrolled in the ongoing Phase IIb study with pirepemat and a reduction in the number of cases has been observed in the overall patient population.
• In October, the company received positive data from the first part of the Phase I study with the drug candidate IRL757.
• In October, IRLAB receives milestone payment of USD 2.5 million in conjunction with first dosing in a Phase I study with IRL757 in healthy older adults

FINANCIAL OVERVIEW OF THE SECOND QUARTER

• Net sales: SEK 51.8m (SEK 6.9m)
• Operating profit: SEK -72.1m (SEK 145.1m)
• Earnings per share before and after dilution: SEK -1.50 (SEK -2.75)
• Cash and cash equivalents at the end of the period: SEK 90.4m (SEK 118.8m)
• Cash flow from operations: SEK 43.0m (SEK 131.0m)
• Share price at the end of the period: SEK 12.7 (SEK 7.38)

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.