CEO Comments Q1 2022

In the first quarter, IRLAB achieved several new milestones. We presented a new drug candidate, IRL757, with high hopes that it will improve the quality of life for all those who currently have apathy – a debilitating symptom in many neurological diseases, such as Alzheimer’s and Parkinson’s. The strengthened cash position after the mesdopetam deal and the resources that were freed up in the R&D organization allow an increased focus on our preclinical operations, and we are very pleased to have been able to deliver a new drug candidate in our project portfolio so soon. During the period, we continued to grow and added additional expertise to our business, and the response on our capital markets day in March was very positive, which confirmed our growth strategy. We are approaching the second half of 2022, and we have already added several important building blocks in the continued exciting progress towards better drugs for those living with Parkinson’s.

One of our key strategic goals is to widen our portfolio and start additional clinical development programs. In the first quarter of the year, we therefore accelerated the development in our preclinical programs with an additional drug candidate, IRL757. The major license agreement* that was concluded with Ipsen in 2021 regarding the development and commercialization of mesdopetam placed us in a strong position and gave us a cash injection. We therefore have the resources needed to continue building our uniquely effective R&D operations.

Our development programs are expanding

We are currently investing fully in our two promising drug candidates from the P001 research project: IRL942, for the treatment of cognitive impairment, and IRL757, for the treatment of apathy in people with neurological disorders. Both drug candidates represent an entirely novel class of drugs, discovered by IRLAB, and addresses neurological conditions for which there is no approved treatment at present or where the treatment is ineffective or causes side effects that limit its use. Our drug candidates in this novel class of drugs have great potential to improve the quality of life for these patients. We are now working intensely in the IRL942 and IRL747 programs to take the next step and proceed to clinical studies. We estimate that Phase I studies will begin in the first and second half of 2023, respectively, provided positive results from the preparatory studies and regulatory approvals are obtained.

The development in our other preclinical research project, P003, which aims to develop an entirely novel treatment for the hallmark symptoms of Parkinson’s, with the potential to replace levodopa, was the reason we made into an important acquisition after the end of the quarter. Our acquisition of know-how, specific knowledge linked to innovative chemistry and patents, will increase our chances of obtaining strong patent protection and filing more patent applications of relevance to the substances included in the P003 projects. This also means that we can now invest in the development of potentially ground-breaking drugs for all people with Parkinson’s.

New drug candidates on the way to clinical development

The P001 project, which represents an entirely new class of drug candidates with major therapeutic and commercial potential, includes two strong development candidates: IRL942, for the treatment of cognitive impairment, and the newly selected IRL757, for the treatment of apathy in neurological diseases. Today, some 12 percent of all people over the age of 65 suffer from cognitive impairment. Apathy is one of the most common, and currently untreated, complications in Parkinson’s, Alzheimer’s and other dementia-related illnesses. Between 20 and 80 percent of all those with neurological ill-health suffer from apathy. IRL942 and IRL757 have been tailored to treat these symptoms. There is no approved treatment for apathy at present – which makes IRLAB a pioneer in this area as well.

In the P003 project, we are working on a potentially revolutionary principle for the treatment of the hallmark symptoms of Parkinson’s disease. Our vision in this project is to develop a drug that may replace levodopa altogether. Over the year, we have laid the foundation for this goal by forming connections with experts in this field, incorporating new experimental models in our ISP platform and discovering chemical leads that may result in the best drug candidates in this area.

The Phase IIb/III study with mesdopetam continues

The development of mesdopetam towards a future marketing authorization progresses well in collaboration with our partner Ipsen. Our collaboration with Ipsen is well organized, and Ipsen is now taking over an increasing amount of the operational work in the preparation for the next development stage. The recruitment of patients for the study continues around Europe and in the US, with the aim of reporting the topline results from the ongoing Phase IIb/III study in the second half of 2022.

The Phase IIb study with pirepemat has begun

Our other clinical drug candidate, pirepemat, is being developed to reduce falls and injuries from falls in people with Parkinson’s. Having received regulatory approvals last winter from the countries in Europe that will participate in this important study, we have now initiated the Phase IIb clinical trial in France, Germany, Poland, Spain, Sweden.

External impact on our studies

From a global perspective, biotech companies had to delay the start of studies or interrupt studies prematurely in 2021–2022, and many studies were hampered by slow patient recruitment. In connection with the spreading of the Omicron variant of Covid-19 in the beginning of the year, it became clear that patient recruitment for clinical trials declined. All companies in the industry also experienced longer response times from regulatory authorities during this period. We are therefore particularly pleased that the mesdopetam study was able to proceed and that we were granted regulatory approvals for the pirepemat study, even though people with Parkinson’s belong to the elderly at-risk group who were advised to isolate and avoid unnecessary medical appointments.

We must be prepared for the impact of a potential increase in the rate of infection and the war in Ukraine may have on the recruitment rate for our clinical studies, chiefly in Europe. Delays in global trade may also impact the supply of input goods that are necessary for our operations. We are continuously taking measures to reduce the risk of impact on our research and clinical studies.

A growing organization

In the first quarter of the year, our organization kept growing. Additional expertise was added that strengthens our operations in various ways, including in the calculation team, which is central to our AI-based research methodology, and a broadening of our IR function, now with a stronger focus on activities in the US.

I would also like to mention that we received plenty of positive feedback from various players in the market after our very first capital markets day. A recording of the event is available on our website for those who missed it. The international experts in our prioritized therapeutic areas who participated as speakers were particularly well received, and they attested to the actual potential of our drug candidates to meet major patient needs in the future. For me, this is an important signal that we are taking the right actions and have high credibility. We look forward to making this an annual event, so that we can offer shareholders, analysts and media more insights into the company and our growth strategy.

Progress in 2022

To conclude, I am happy to say that the beginning of 2022 involved significant progress. We strengthened our organization as well as our preclinical programs and research projects. We are constantly aiming for our strategic goal of expanding our clinical development portfolio while supporting our business goals and creates value for patients, shareholders and society.

Nicholas Waters, CEO, IRLAB

* Mesdopetam is developed in partnership with Ipsen, who has licensed global and exclusive rights from IRLAB to develop and commercialize mesdopetam.