IRLAB publishes interim report for April 1 – June 30, 2021

Significant events during second quarter (April 1 – June 30, 2021)

• On May 6, the company’s annual general meeting was conducted solely through postal voting due to the covid-19 pandemic.
• In May, a scientific paper reporting the clinical phase I study results for drug candidate mesdopetam was published in the journal Pharmacology Research & Perspectives (PR&P). The published paper strengthens the growing scientific evidence of the drug candidate mesdopetam’s significant potential in Parkinson’s.
• In June, it was announced that equity research company Edison initiates coverage of the company.
• In mid-June, a scientific publication reporting the results from the clinical first-in-human study with pirepemat was published in the journal Clinical Pharmacology in Drug Development (CPDD). Publication of results from preclinical and clinical studies are an important part of drug development and is at the center of the company’s strategy to establish IRLAB’s science and pipeline broadly academically as well as in the industry.

Significant events after end of period

• In July, it was announced that the global biopharmaceutical company Ipsen and IRLAB entered a licensing agreement, providing Ipsen exclusive worldwide development and commercial rights to mesdopetam, a novel investigational drug candidate for the treatment of dyskinesia and psychosis in Parkinson. IRLAB will continue to be responsible for the ongoing Phase IIb trial that started in autumn 2020. Ipsen will take over and drive the preparatory activities for the upcoming Phase III trial and will be responsible for all remaining clinical development and worldwide commercialization. IRLAB is eligible to receive up to $363m, including a $28m upfront payment, corresponding to approximately SEK 240m which has been paid out after the end of the reporting period, and up to $335m in potential development, regulatory and sales-based milestones, plus tiered low double-digit royalties on worldwide net sales.

Financial overview

CEO’s comment
During the first half of the year, the business delivered several successes that culminated in the exclusive global licensing agreement for mesdopetam with the pharmaceutical company Ipsen, which was signed in mid-July. This is a very impressive milestone in the company’s history. According to the agreement, IRLAB is eligible to receive up to $363 million, across an up-front of $28 million and up to $335 million in potential milestone payments. IRLAB is, in addition, entitled to royalties that increase in line with the global net sales. The deal is one of the largest made within Swedish biotech and provides us a completely new position to further increase the activities of the research platform ISP, focus on the pirepemat project and take our preclinical projects to clinical development and studies.

Ipsen – an optimal partner for IRLAB
Ipsen shares IRLAB’s broad vision for mesdopetam and its commitment for people with neurological diseases. Ipsen has a global presence with products in neurology, an experienced development and marketing organization and a strategy focusing on neurological diseases. This provides very good conditions for Ipsen to successfully bring mesdopetam to the market and achieve high sales. We are therefore very happy to be able to complete the final steps toward a market launch in a fully-funded partnership with just Ipsen. The agreement is also a clear external validation of our research platform, ISP, our drug development operations, and our business strategy.

The licensing agreement with Ipsen is one of the largest deals struck within Swedish biotech, which is a merit both for IRLAB and for those who have supported the mesdopetam project to this milestone. It also shows that IRLAB has succeeded to deliver on the business strategy of developing drug candidates until proof-of-concept.

Another important outcome of the mesdopetam deal is that we can now allocate more resources to our other development projects; the upfront payment provides an immediate and significant reinforcement of our cash position and, in addition, Ipsen takes over the cost responsibility for the preparatory activities ahead of Phase III studies.

Ongoing Phase IIb/III study with mesdopetam
IRLAB will continue to be both financially and operationally responsible for completing the ongoing Phase IIb study with mesdopetam that is now ongoing in the US and Europe. In parallel, Ipsen will take over the work with the preparatory activities for Phase III studies. The transition time between Phase II and Phase III is thus minimized.

Phase IIb study with pirepemat
Pirepemat, the second drug candidate in our clinical pipeline, is the first in a completely new class of drugs discovered using our ISP technology. Pirepemat is being developed for the treatment of balance impairment and falls in Parkinson’s. The aim is to give people with Parkinson’s improved balance and prevent falls and fall injuries, which are commonly occurring, thus providing the opportunity for improved quality of life.

IRLAB is now intensifying the work on the upcoming Phase llb study. The drug candidate will be administered during 12-weeks to evaluate the effect on fall frequency compared with placebo.

Continued spotlight of IRLAB’s projects through scientific publications
During the quarter, two new publications have been published in renowned scientific publications, which contributes to strengthening IRLAB’s position within our business area. Both articles present the results from respective Phase I study with mesdopetam and pirepemat.

Outlook
Our business goal is to continue to expand and capitalize on the ISP platform, now with more resources than we previously have had available. We have evaluated application of AI methodology on our ISP database and the results support use of deep learning as a valuable addition to the machine learning methods we already use today in our systems biological research platform.

The ISP technology is the key to the rapid and successful development of our clinical drug candidates mesdopetam and pirepemat. We now know that our business development strategy clearly support our business model and we will continue to work towards new income generating opportunities. We also see that there may be commercial potential for an AI-based systems biological research platform and are evaluating the conditions to develop ISP to a dedicated business area.

Following the mesdopetam deal with Ipsen and our reinforced financial position, we can make new priorities in our investments. IRLAB will put an added focus on pirepemat. In addition, we have a solid portfolio of preclinical projects and drug candidates in our pipeline, discovered with the help of ISP, that we now will bring forward through preclinical development toward Phase I clinical studies. The company is currently in an expansion phase, and we will during the year recruit more new colleagues with specialist competence in R&D, market, analysis and within administrations.

Impact of the Covid-19 pandemic
Concerning our clinical programs, we see indications that the situation at healthcare providers in certain countries and regions is under pressure, which affects the hospitals’ ability to participate in clinical trials. We also note that regulatory authorities have longer processing times. Combined, this may come to affect IRLAB’s clinical trials. We therefore follow the situation closely and evaluate measures to minimize the impact on our projects and timelines.

August 2021
Nicholas Waters, CEO IRLAB Therapeutics

Financial calendar
Interim report July – September 2021: November 10, 2021
Year-end report 2021: February 23, 2022