IRLAB Therapeutics: publishes an interim report from April 1 to June 30, 2021

Important events during the second quarter (April 1June 30, 2021)

  • At May 6, the company’s annual general meeting was held only by mail ballot due to the covid-19 pandemic.
  • In May, a scientific article reporting the results of the phase I clinical study for the drug candidate mesdopetam was published in the journal Research and perspectives in pharmacology (PR&P). The published article strengthens the growing scientific evidence of the significant potential of the drug candidate mesdopetam in Parkinson’s disease.
  • In June, it was announced that stock research firm Edison is initiating coverage for the company.
  • In mid-June, a scientific publication reporting the results of the first human clinical study with worsepemat was published in the journal Clinical Pharmacology in Drug Development (CPDD). The publication of the results of preclinical and clinical studies is an important part of drug development and is central to the company’s strategy to establish the science and pipeline of IRLAB at the academic level as well as in industry.

Important events after the end of the period

  • In July, it was announced that global biopharmaceutical company Ipsen and IRLAB had entered into a licensing agreement, granting Ipsen exclusive worldwide rights to develop and commercialize mesdopetam, a new investigational drug candidate for the treatment of dyskinesia and psychosis in Parkinson’s disease. IRLAB will continue to be responsible for the ongoing Phase IIb trial which began in fall 2020. Ipsen will take over and lead the preparatory activities for the next Phase III trial and be responsible for all remaining clinical development. and global marketing. The IRLAB is eligible to receive up to $ 363 million, including a $ 28 million initial payment, corresponding to approximately 240 m SEK that was paid after the end of the reporting period, and up to $ 335 million in potential development, regulatory and sales-based milestones, as well as double-digit tiered royalties on global net sales.

Financial overview

(TSEK) 2021
April June
April June
January June
January June
Operational results -26,521 -26,103 -46 487 -45 164 -91,458
Result for the period -26 629 -26,154 -46 670 -45,272 -91 653
Earnings per share before and after dilution attributable to shareholders of the parent company -0.51 -0.54 -0.90 -0.97 -1.92
Number of shares at the end of the period, incl. shares subscribed but not yet registered 51 748 406 48,498,406 51 748 406 48,498,406 51 748 406
Cash and cash equivalents 229,383 201 784 229,383 201 784 277,009
Equity per share 5.82 5.61 5.82 5.61 6.72
Average no. employees 21 19 20 19 18
of which in R&D 19 17 18 17 17

CEO Commentary
During the first half of the year, the activity achieved several successes which led to the exclusive worldwide license agreement for mesdopetam with the pharmaceutical company Ipsen, signed in mid-July. This is a very impressive milestone in the history of the company. According to the agreement, IRLAB is eligible to receive up to $ 363 million, on a front of $ 28 million and up to $ 335 million in potential milestone payments. The IRLAB is, moreover, entitled to royalties which increase according to the total turnover. The deal is one of the largest in Swedish biotechnology and gives us a whole new position to further increase the activities of the ISP research platform, focus on the worstpemat project and bring our preclinical projects to the next level. development and clinical studies.

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

The license agreement with Ipsen is one of the most important agreements reached within Swedish biotechnology, which is a merit both for IRILAB and for those who have supported the mesdopetam project up to this stage. This also shows that the IRLAB has succeeded in implementing the commercial strategy of developing drug candidates up to proof of concept.

Another important result of the mesdopetam agreement is that we can now allocate more resources to our other development projects; the initial payment provides an immediate and significant strengthening of our cash flow and, in addition, Ipsen covers the costs of the preparatory activities upstream of the Phase III studies.

Phase IIb / III study underway with mesdopetam
IRIB will continue to be both financially and operationally responsible for the completion of the ongoing Phase IIb study with mesdopetam which is currently underway in the United States and Europe. At the same time, Ipsen will resume work with preparatory activities for the Phase III studies. The transition time between Phase II and Phase III is thus minimized.

Phase IIb study with worsepemat
Pirepemat, the second drug candidate in our clinical pipeline, is the first in a whole new class of drugs discovered through our ISP technology. Pirepemat is developed for the treatment of balance disorders and falls in Parkinson’s disease. The aim is to give people with Parkinson’s disease a better balance and prevent falls and fall injuries, which occur frequently, thus offering the possibility of a better quality of life.

IRLAB is currently intensifying work on the next Phase llb study. The drug candidate will be administered for 12 weeks to assess the effect on the frequency of falls compared to placebo.

Continuous spotlight on IRIAB projects through scientific publications
During the quarter, two new publications were published in renowned scientific publications, which contributes to strengthening IRIAB’s position within our field of activity. The two articles present the results of the respective phase I study with mesdopetam and worstpemat.

Our business goal is to continue to grow and capitalize on the ISP platform, now with more resources than we previously had. We evaluated the application of the AI ​​methodology on our ISP database and the results support the use of deep learning as a valuable addition to the machine learning methods we already use today. hui in our Biological Systems Research platform.

ISP technology is key to the rapid and successful development of our clinical drug candidates mesdopetam and worsepemat. We now know that our business development strategy clearly supports our business model and we will continue to work towards new income generating opportunities. We also see that there might be commercial potential for a biological research platform on AI-based systems and assess the conditions for developing ISP in a dedicated business area.

Following the mesdopetam agreement with Ipsen and our strengthened financial situation, we can define new priorities in our investments. IRLAB will put additional emphasis on direpemat. Additionally, we have a strong portfolio of preclinical projects and drug candidates in our pipeline, discovered with the help of ISP, which we will now advance through preclinical development into Phase I clinical studies. is currently in an expansion phase and during the year we will recruit more new colleagues with specialized skills in R&D, market, analysis and within administrations.

Impact of the Covid-19 pandemic
Regarding our clinical programs, we are seeing indications that the situation of healthcare providers in some countries and regions is under pressure, which affects the ability of hospitals to participate in clinical trials. We also note that regulatory authorities have longer processing times. Taken together, this could affect clinical trials for IRLAB. We are therefore monitoring the situation closely and evaluating measures to minimize the impact on our projects and our schedules.

August 2021Nicolas Waters, CEO IRLAB Therapeutic

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

Margie D. Carlisle