IRLAB publishes Year-end report for the period January-December 2022

SUMMARY OF THE FOURTH QUARTER

• The final patient completed the treatment period and follow-up visit (“Last Patient Last Visit”) in the Phase IIb study of mesdopetam in levodopa-induced dyskinesia in people with Parkinson’s disease (PD-LIDs) in mid-December.
• IRLAB shared new preclinical data providing insight into the mechanisms underlying antipsychotic and antidyskinetic efficacy of drug candidate mesdopetam (IRL790) in PD-Psychosis and PD-LIDs. The research was conducted by an independent academic research group led by Prof. Per Petersson at Lund and Umeå University and presented at the premier congress Neuroscience 2022.
• The nomination committee was appointed ahead of the annual general meeting (AGM) 2023 and comprises Hans-Peter Ostler, Anders Vedin, Clas Sonesson, and Gunnar Olsson, Chairperson of IRLAB Therapeutics AB.
• IRLAB presented at several national and international investor events to provide a business update of the company’s progress e.g. at DNB Nordics Healthcare Conference, LSX Inve$tival Showcase, Redeye Life Science Day and SEB Annual Healthcare Summit. Public recordings are available on the website, irlab.se.

EVENTS AFTER THE END OF THE PERIOD

• IRLAB was invited to participate at the 6th Neuroscience Innovation Forum hosted by Sachs Associates in early January. The event was held in connection to the Annual J.P. Morgan Healthcare Conference, in San Francisco, US.
• Drug candidate IRL1117 was nominated from the P003 research project in early January. IRL1117 will be developed as a once-daily oral treatment for the hallmark symptoms of Parkinson’s without inducing the troublesome complications caused by today’s mainstay anti-Parkinson’s levodopa treatments.
• The top-line results from the Phase IIb study of mesdopetam in people with Parkinson’s disease levodopa-induced dyskinesias (PD-LIDs) were announced in mid-January. Mesdopetam demonstrated dose dependent anti-dyskinetic effects in several dyskinetic assessment scales with an adverse event and tolerability profile similar to placebo, even though the study did not statistically meet the primary efficacy endpoint of “good ON”-time. Additional analysis of the full data is currently ongoing.
• In mid-February, the company announced an update to the portfolio development milestones following an assessment of the operational priorities for 2023.
• On February 20, IRLAB’s CEO Richard Godfrey was replaced by Gunnar Olsson who was appointed as interim CEO. Carola Lemne, former Vice Chair, took over the role as Chair of the Board from Gunnar Olsson. The process to recruit a permanent CEO is initiated immediately.
• As the new Chair of the Board of IRLAB, Carola Lemne takes over the membership in the nomination committee after Gunnar Olsson’s resignation as Chair of the Board.
• An van Es-Johansson has elected to leave her assignment as a Board member at IRLAB.

FINANCIAL HIGHLIGHTS IN THE FOURTH QUARTER

• Net sales recorded: SEK 12.2m (SEK 12.1m)
• Total operating expenses: SEK 45.8m (SEK 35.0m)
• The operating result: SEK –33.1m (SEK -23.1m)
• Cash flow from operations: SEK –37.9m (SEK -28.4m)
• Cash and cash equivalents at the end of the period: SEK 252.8m (SEK 401.9m)
• The total number of registered shares: 51,868,406 (51,748,406

Figures in brackets = same period 2021, unless otherwise stated

PRESENTATION TO INVESTORS AND MEDIA

A presentation will be held on February 23, 2023, at 10:00 CET via an online webcast. CEO Gunnar Olsson and EVP and Head of R&D Nicholas Waters will comment the year-end report for the period January-December 2022. The presentation will be held in English and followed by a Q&A session.

Follow the presentation online on: https://www.youtube.com/watch?v=YbKsH6TDFqM

COMMENTS FROM THE CEO
As we close on 2022 and reflect on the company’s development during the year, we are pleased to report continued significant progress in our broad portfolio of innovative drug candidates. Each with the potential to address the great unmet needs of people living with Parkinson’s disease. The Phase IIb data of mesdopetam, which were presented after the end of the reporting period, continues to be analyzed in detail. Although the study did not meet its primary endpoint, several important objectives were achieved and we remain optimistic about the drug candidate’s potential to improve the life situation of millions people with Parkinson’s around the world.

Completion of the Phase IIb study of mesdopetam – an important milestone
The recently reported top-line data from our Phase IIb study of mesdopetam in people with Parkinson’s disease levodopa-induced dyskinesias shows we did not meet statistical significance of the primary endpoint in the study – “good ON”-time – compared to placebo. We are, however, encouraged that the established efficacy measurement for anti-dyskinetic effect taking both objective physician ratings and patient ratings into account, UDysRS, demonstrated statistically significant and dose dependent effects by mesdopetam, without impairing normal motor function. We also noted an apparent reduction in OFF-time. The Phase IIb study further confirmed the favorable safety and tolerability profile of mesdopetam – in line with placebo treatment. The study also achieved its objective to establish the best dose to be used in further clinical studies. We continue with detailed analyses of the data from the study in collaboration with our partner Ipsen.

As with all clinical development, this Phase IIb study also had objectives to provide additional data to increase confidence in the safety and tolerability of mesdopetam in people with Parkinson’s and also to inform on the preferred dose to be used in further clinical studies. We have recently received the full data set from the trial and continue with thorough detailed analysis in collaboration with our partner Ipsen. In recent weeks, we have had the opportunity to discuss these top-line results with key opinion leaders, industry executives, and expert regulatory advisors. Despite the missed primary
efficacy endpoint, they are equally hopeful of the clinical efficacy observed and the potential for mesdopetam to be an effective treatment of Parkinson’s disease.

We now have a substantial body of evidence for mesdopetam’s potential supported by results from clinical Phase Ia, Phase Ib, Phase IIa, and Phase IIb studies where each study has achieved its respective purpose in the different steps of the drug development process. Overall, this clinical package provides a strong basis for the design of the continued clinical development program toward marketing registration of a new drug.

Progress of pirepemat in Phase IIb
Pirepemat, our second candidate in Phase IIb, is being developed to improve balance and reduce falls for people living with Parkinson’s. This is one of the greatest medical needs in Parkinson’s. A reduced fall frequency results in fewer fall-related injuries, improved quality of life, decreased stress for caregivers as well as decreased costs for the healthcare system.

The Phase IIb study is recruiting people with late-stage Parkinson’s with mild cognitive impairment and at least two falls during the 6-week screening. The study objective is to find the optimal dose and to evaluate pirepemat’s dose-dependent efficacy on falls, cognitive function, and psychiatric symptoms. Additionally, the study will further add to the knowledge of the drug candidate’s safety and tolerability profile. This study is currently active at 28 out of 39 planned sites in five European countries. In parallel, we continue with the preclinical work recommended by the FDA and believe this will be finalized in the second quarter 2023.

The initial patient recruitment was a little slower than the estimated timeline and we have taken steps to address this. We estimate that the study will be fully recruited by the year-end 2023 and that top-line results will be reported in H1 2024.

Expanding preclinical portfolio
We continue to make excellent and exciting progress with the P003 project with the designation of IRL1117 being identified as our lead compound, which was announced in early January. IRL1117 is being developed as a completely novel, orally administered once-daily Parkinson’s treatment, without the troublesome complications of current standard-of-care levodopa treatment or treatments in the development pipeline.

The company’s three preclinical programs; IRL942, IRL757, and IRL1117 are proceeding according to their respective updated preclinical development, toxicology and GMP manufacturing plans. IRL942, in development for cognitive decline in neurological disorders, is expected to be Phase I ready during H1 2024. IRL757, in development for apathy in neurological disorders, is expected to be Phase I ready by year-end 2023. In the IRL1117 program, we continue the work in preparation for Phase I enabling toxicology and manufacturing activities that are expected to be initiated in 2024.

Visibility and conference participation
In January, we attended the 6th Annual Neuroscience Innovation Forum in San Francisco USA, where we participated in panel discussions regarding ‘New Approaches to Parkinson’s and Movement Disorders’. In addition, we also presented IRLAB’s research platform, portfolio and outlook.

We will have a significant presence at the forthcoming scientific congress International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders, AD/PD 2023, in our hometown Gothenburg on March 28-April 1. The company will participate with three poster presentations and an oral presentation related to our preclinical candidates and ISP. We are also organizing a symposium in the afternoon of March 31 focusing on living with Parkinson’s, disease journey, diagnosis, biomarkers, treatments and emerging therapeutics, and the impact on family and society.

We also look forward to presenting more comprehensive data and analyses of the Phase IIb trial of mesdopetam at forthcoming scientific and medical congresses during spring.

Forward-looking
We will complete the full analysis of the data from the Phase IIb study in collaboration with our partner Ipsen, and we are optimistic that the results will confirm the potential of mesdopetam as an effective treatment for Parkinson’s disease. We further work according to the outlined company’s strategic priorities for 2023 with a focus on carrying out the Phase IIb study of pirepemat and developing the preclinical candidates towards Phase I according to the respective development plan. Activities related to partnering and business development are also ongoing in parallel with the research and development activities.

The cash flow for the fourth quarter of 2022 was SEK –37.9 million and the cash balance at the end of the quarter amounted to 252.8 million crowns. This, along with rapid progress in our broad project portfolio of potentially groundbreaking drugs, provides a solid basis for our efforts to improve treatment options for people living with Parkinson’s disease.

Following the recent departure of Richard Godfrey, I am grateful to have been entrusted to lead the company in close cooperation with the company management. I would like to conclude by thanking Richard for his contribution during his time at IRLAB. I look forward to updating you regularly about the further development of IRLAB and our drug development projects.

Gunnar Olsson, CEO, IRLAB