IRLAB’s Year-end report January 1 – December 31, 2020

Significant events during the fourth quarter (October 1 – December 31, 2020)

• In October, the US FDA accepted mesdopetam as an investigational new drug (IND). The acceptance allows IRLAB to include patients in the US in the clinical Phase IIb/III study with mesdopetam in levodopa-induced dyskinesias in Parkinson’s (PD-LIDs).
• Early November, patient recruitment started in the US to the Phase IIb/III study with mesdopetam in PD-LIDs and the first patients started treatment before end of year.
• In the beginning of December, the World Intellectual Property Organization (WIPO) published a new patent application for the drug candidate mesdopetam. This composition of matter patent could extend the market exclusivity for mesdopetam with up to eight years compared with existing patent protection, which would mean the protection stretches into the 2040s.
• In December, a directed share issue was carried out in the amount of 130 MSEK. The share issue facilitates an increased institutional ownership, larger investments in the company’s clinical projects with the purpose to accelerate the generation of study results and to begin preparations for the next development phase.

Significant events after the reporting period

• In January, new preclinical data were presented that indicates that not only can mesdopetam treat, but also prevent, the development of levodopa-induced dyskinesias (LIDs) in Parkinson’s. The new results increase the commercial potential of mesdopetam.

• In January, results were presented from a collaboration with Chalmers University of Technology, AI-company Smartr and IRLAB about the application of deep learning on multidimensional effects of CNS drugs. A summary of the interesting results were presented at the leading congress Society of Neuroscience (SfN) Global Connectome: A Virtual Event.

Financial overview (October 1 – December 31, 2020)

CEO’s comments

During the fourth quarter, we raised additional capital to continue to develop the company at a high pace, primarily to accelerate our Phase IIb/III studies and prepare for future Phase III studies. The start of the clinical Phase IIb/III study with mesdopetam was one of the highlights during the quarter and the first patients began their treatment at the end of the year. We were also excited over the new preclinical results indicating that mesdopetam may slow the progression of disease symptoms, which has long been a highly sought-after goal. All in all, we enter 2021 strengthened with a focus on our clinical Phase IIb projects, preclinical projects in late development phase and to improve our research platform ISP.

Successful capital raising

We enter 2021 with an increased financial strength following the share issue in December. The additional capital and the broadened shareholder base enable us to continue to develop the company at a high pace. More specifically, we will have the possibility to increase resources in our clinical studies and to accelerate the crucial preparatory work for Phase III studies with the aim of minimizing the time to launch of marketing authorized drugs. It also means that we are now expanding our capacity in communications and administration as well as attracting new expertise within clinical development and research, based on our unique discovery research platform, ISP.

First patients receive treatment with mesdopetam in our Phase IIb/III study

During the fourth quarter, recruitment of patients began for the Phase IIb/III study with mesdopetam. First out was the US and in parallel, with additional US centers recruiting patients, we are now working intensively together with our partners to begin treatment of patients in Europe.

New patent applications extend market exclusivity

The new patent application for mesdopetam that was published during the quarter increases the commercial potential for the drug candidate. The patent may come to extend the market exclusivity by up to eight years compared with current patent protection, which would result in protection for mesdopetam by two solid patent families stretching a bit into the 2040s.

Mesdopetam can prevent dyskinesia – significantly greater market potential

In parallel with the clinical studies, preclinical studies are ongoing that aims to expand the knowledge about our drug candidates, an important component in the discovery of new clinical applications to reach a greater market potential.

At the leading neuroscience conference SfN Global Connectome 2021, which were held in January, preclinical results were presented indicating that mesdopetam, in addition to treat already developed dyskinesias, also can be used to prevent them. Should future studies in patients confirm these results, mesdopetam could contribute to slow the progression of disease symptoms, which has long been a highly sought-after goal within research and highly anticipated by patients. This would significantly increase the number of patients who could benefit from mesdopetam but also the time during which they benefit from the drug.

Pirepemat being prepared for Phase IIb

The next development step for pirepemat is to study the effect on impaired balance and falls in Parkinson’s. During the quarter, we worked with complementary studies that are part of the documentation needed to obtain approval to start the next study. The aim is to start the Phase IIb study with pirepemat during the first half of 2021.

Leading within technology development

With modern artificial intelligence (AI)-based methods to develop novel and better drugs, IRLAB leads the technology development within systems biology-based drug discovery in the CNS space. In collaborations with Chalmers University of Technology, Smartr’s specialists on AI and scientific advisors, we continue to refine the computation models in our research platform ISP. The combination of our systems biology ISP database and advanced AI-based calculations is an essential part of our business and strengthens our competitiveness and generates innovative drug candidates and development programs. We have obtained a seal of quality on the power of innovation in ISP by the fact that ISP-generated mesdopetam and pirepemat both now have external validation though the WHO’s INN assessment that they are so innovative that they are recommended to represent completely new drug classes.

Impact of covid-19 on our operations

During the year, IRLAB has adapted its operations following guidelines set by authorities and legislators because of the covid-19 pandemic. We work from home when possible and help to responsibly protect our community. The adaptions have enabled us to plan the operations and carry out work so that it is not affected by the pandemic to any significant extent. However, in interactions with authorities and certain suppliers, we have during 2020 seen that decisions and deliveries have been taking somewhat longer due to the pandemic.

In the ongoing clinical study with mesdopetam, we have not yet seen any effect on the possibility of recruiting patients, however, any effect cannot be ruled out in the future. We carefully follow the developments and have prepared measures aimed at minimizing the risk that IRLAB’s clinical studies and research activities are affected.

Priorities ahead

The company's most important priority is to ensure that the clinical projects are run efficiently and according to plan. We have linked world-leading experts in Parkinson's and clinical drug development to the mesdopetam and pirepemat projects, with the task of supporting patient recruitment and ensuring that time schedules are met.

With active studies in both projects in clinical phase later this year, we can increase the internal resources on the preclinical programs P001 and P003 as well as refine and strengthen the research platform ISP. The goal is to become even more efficient in the development of our clinical programs and to further increase the precision in the discovery and development of drug candidates with good safety and efficacy.

Gothenburg, February, 2021

Nicholas Waters, CEO of IRLAB Therapeutics AB

Financial calendar

Annual report                                                             week 15, 2021

Interim report January – March, Q1 2021                 May 6, 2021

AGM 2021                                                                 May 6, 2021

Interim report January – June, Q2 2021                    August 25, 2021

Interim report January – September, Q3 2021          November 10, 2021

Year-end report January – December, Q4 2021       February 23, 2021

For more information

Nicholas Waters, CEO
Phone: +46 730 75 77 01, E-mail: nicholas.waters@irlab.se

Viktor Siewertz, CFO
Phone: +46 (0)727 10 70 70; E-mail: viktor.siewertz@irlab.se

About IRLAB

IRLAB is a Swedish research and development company that focuses on developing novel treatments in Parkinson’s disease. The company's most advanced candidates, mesdopetam (IRL790) and pirepemat (IRL752), both of which completed Phase IIa-studies, intends to treat some of the most difficult symptoms related to Parkinson's disease: involuntary movements (PD-LIDs), psychosis (PD-P) and symptoms linked to cognitive decline such as impaired balance and increased risk of falls (PD-Falls). Through the proprietary research platform, ISP (The Integrative Screening Process), IRLAB discovers and develops unique drug candidates for central nervous system (CNS) related disorders where large and growing medical need exist. In addition to the clinical candidates, the ISP platform has also generated several CNS programs that are now in preclinical phase. IRLAB is listed on Nasdaq Stockholm Main Market. More information on www.irlab.se.