IRLAB publishes interim report for the period January-March 2023

SUMMARY OF THE FIRST QUARTER

• 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 in early January as a new addition to the company’s portfolio. IRL1117 is now under development as an innovative once-daily treatment for the hallmark symptoms of Parkinson’s without inducing the troublesome fluctuations in effect and complications caused by today’s mainstay levodopa-based treatments.
• The top-line results of the Phase IIb study of mesdopetam in people with Parkinson’s disease levodopa-induced dyskinesias were reported in the middle of January 2023. While the study did not reach statistical significance in the primary endpoint, it achieved its purpose of confirming dose-dependent effects and the selection of best dose for further clinical studies. Mesdopetam demonstrated clear anti-dyskinetic effects during the full 12-week treatment period with an adverse event and tolerability profile at the same level as placebo. The anti-dyskinetic effects were achieved without reducing normal motor function and are further strengthened by a clear reduction of OFF-time. Detailed analyses of the full data set from the study are ongoing in collaboration with our partner Ipsen.
• 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, Dr Gunnar Olsson, M.D., Ph.D was appointed as interim CEO following Richard Godfrey’s termination. Carola Lemne, former Vice Chair, took over the role as Chairperson of the Board from Gunnar Olsson, and An van Es-Johansson elected to leave her assignment as a Board member at IRLAB on February 21. As the new Chairperson of the Board of IRLAB, Carola Lemne took over the membership in the nomination committee after Gunnar Olsson’s resignation as Chairperson of the Board.
• At the end of March, IRLAB presented new data related to the preclinical drug candidates and the ISP platform in an oral presentation and in three poster presentations at the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, AD/PD ™ 2023.
• IRLAB organized an industry symposium at the scientific congress AD/PD ™ 2023, which was held on Friday, March 31, 2023. A recording of the symposium titled The management dilemma of Parkinson’s disease progression and emerging treatment approaches can be found on IRLAB’s website, www.irlab.se.
• IRLAB presented at national investor events and are regularly interacting with potential national and international investors to provide an update on the company and its progress. The events were organized by e.g., ABGSC. Public recordings are available on IRLAB’s website, www.irlab.se.

EVENTS AFTER THE END OF THE PERIOD

• On May 3, IRLAB was made aware that Ipsen’s 2022 Universal Registration Document, published on April 6, 2023, contains the incorrect information that the development and commercialization rights for mesdopetam have been transferred back to IRLAB. This is incorrect. Following contact from Ipsen on May 1, 2023, a discussion was initiated with IRLAB to mutually agree on the best way forward to secure that the mesdopetam program gets the best possible prospects to reach registration and to ensure that mesdopetam can be made available to the benefit of all people living with Parkinson’s disease.

FINANCIAL HIGHLIGHTS IN THE FIRST QUARTER

• Net sales recorded: SEK 0 (SEK 9.0m)
• Total operating expenses: SEK 59.5m (SEK 38.2m)
• The operating result: SEK –59.5m (SEK –29.1m)
• Cash flow from operations: SEK –41.5m (SEK -28.4m)
• Cash and cash equivalents at the end of the period: SEK 210.1m (SEK 368.0m)
• The total number of registered shares: 51,868,406 (51,748,406)

Figures in brackets = same period 2022, unless otherwise stated

PRESENTATION TO INVESTORS AND MEDIA

The presentation will be held on May 10, 2023, at 10:00 CET through an online webcast. Gunnar Olsson, CEO, Nicholas Waters, EVP and Head of R&D, and Viktor Siewertz, CFO, will comment the interim report for the period January-March 2023. The presentation will be held in English and followed by a Q&A session.

Access to the presentation via link: https://youtube.com/live/0OQ8c8kMnaA?feature=share

COMMENTS FROM THE CEO
IRLAB continues to make significant progress in its efforts to develop innovative treatments for Parkinson’s and other neurological disorders. During the first quarter of this year, we achieved important milestones in our clinical development programs, including the completion of the Phase IIb study with mesdopetam. Our second Phase IIb study with pirepemat is progressing as planned. We are also making progress in our preclinical programs and remain confident in the potential of our drug portfolio to address the unmet medical needs, primarily for those living with Parkinson’s.

Restructure of management
Nearly a year has passed since we created separate CEO and Head of Research & Development (R&D) roles within the company’s leadership, instead of having these responsibilities combined into one position as before. The outcome has been that the Head of R&D can now focus on research-related matters, while the CEO’s role is now directed more toward strategic matters, corporate development, and establishing partnerships with other companies. I have been serving as the CEO for almost three months now. Although I had a good understanding of the company from my time in the Board (since 2017), it has been highly positive to become even closer to the operations. This has further reinforced my impressions and confidence in the quality of the operations and its employees. This foundation, combined with our strong project portfolio, provides us with excellent opportunities for continued positive growth.

Clear anti-dyskinetic effects by mesdopetam
In the Phase IIb study with mesdopetam, the efficacy and safety of three dose levels of mesdopetam were evaluated in individuals with Parkinson’s disease experiencing troublesome dyskinesia. The aim was to establish a dose-response relationship to determine the appropriate dose for Phase III. The top-line results of the study were reported in January 2023, and subsequent analysis of the complete dataset has been conducted. Although the primary endpoint in the study, known as “good ON” time, i.e. the change in the duration of time during the day that patients experience the positive effects of levodopa on Parkinson’s hallmark symptoms (tremors, stiffness, and bradykinesia) without troublesome dyskinesia, did not reach statistical significance compared to placebo, the study achieved its objective by establishing a dose-dependent anti-dyskinetic effect accompanied by a good safety and tolerability profile. The study has thus provided information for selecting the dose for Phase III: 7.5 mg twice daily. IRLAB and IRLAB’s regulatory and commercial advisors have a strong belief in the clinical and commercial potential of mesdopetam.

The path forward in the development of mesdopetam
After the completion of Phase I and Phase II study programs, combined with Ipsen’s Phase III preparatory activities, including conducting regulatory pharmacokinetic studies in Phase I, manufacturing of drug substance and drug product, we assess that mesdopetam will be ready for Phase III. Following communication from Ipsen on May 1, 2023, a discussion was initiated with IRLAB to mutually agree on the best way forward to ensure that the mesdopetam program is given optimal opportunities for registration and to ensure that mesdopetam can be made available to all people living with Parkinson’s disease.

Ongoing Phase IIb study of pirepemat
In the ongoing Phase IIb study with pirepemat, the effect of two different doses of pirepemat on the frequency of falls in people with Parkinson’s is evaluated in order to be able to confirm the best dose for use in Phase III. In the study, the effect on cognitive function and safety/tolerability will also be evaluated. We anticipate that all participating clinics in the study will be activated by June 2023. Recruitment of patients is expected to be completed by the end of 2023, followed by a three-month treatment period. Based on the current timeline, top-line results are expected in H1 2024.

Preclinical programs have potential to address major needs
Our drug candidates in the preclinical development phase are progressing as planned to be ready for testing in clinical trials. IRL942 targets the improvement of cognitive function in people with Parkinson’s and other neurological disorders, IRL757 aims to treat apathy in Parkinson’s and other neurological disorders, and IRL1117 with the objective of developing a treatment for the hallmark symptoms of Parkinson’s (tremors, stiffness, and bradykinesia) without causing the troublesome fluctuations of the effect and the complications associated with current mainstay levodopa-based treatments. A drug with this profile has the potential to replace levodopa treatment for Parkinson’s.

Portfolio of drug candidates
Today, we have a world-leading portfolio of innovative drug candidates for treating people with Parkinson’s and other CNS disorders, based on our proprietary research platform, ISP. This positions us strongly to continue developing the company with the goal of bringing new and improved medications for individuals with Parkinson’s across all stages of the disease, which simultaneously could be generating value for our shareholders. Over the next 1-2 years, we could have up to five drug candidates in the clinical development phase – an impressive and possible development for the company that will require further expansion of certain competencies.

Interesting points of view at AD/PD 2023
This year, one of the foremost scientific congresses in the field of CNS took place in our hometown, Gothenburg – the International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders, AD/PD™ 2023. We participated by organizing an industry symposium as an initiative to strengthen our position in the medical community and further showcase our company to raise awareness of our research and development focus and our world-leading drug portfolio among both major and minor pharmaceutical companies. It was interesting to hear our invited panelists, experts in their respective fields, present their experiences and knowledge on the topic of “The management dilemma of Parkinson’s disease progression and emerging treatment approaches.” The audience consisted of approximately 200 people, and questions were posed to the panel by individuals in scientific positions associated with companies such as Biogen, Janssen, Roche, and BioHaven.

Forward-looking
We have our priorities for 2023 defined: providing full support for the planning of Phase III with mesdopetam and together with Ipsen, deciding on the best path forward for Phase III implementation; completing patient recruitment in the ongoing Phase IIb study with pirepemat; finalizing preclinical development ahead of a clinical trial this year for IRL757, and advancing IRL942 and IRL1117 in preclinical development in preparation for clinical trials next year. With our broad project portfolio of drug candidates in the development phase, we will need to continue driving efficient cost management. Like other biotech companies, we will require capital injections, which can be achieved through licensing agreements/collaborations or through the capital market. While we are currently relatively well-capitalized, we need to remain vigilant about our financial stability, and we continuously evaluate our opportunities. I look forward to continuing to develop the company and our drug candidates together with our employees and the Board, and I want to express my gratitude to all shareholders for the support and trust you have placed in us.

Gunnar Olsson, CEO, IRLAB