IRLAB publishes interim report for the period January–September 2022

SUMMARY OF THE THIRD QUARTER

• IRLAB’s Phase IIb study of mesdopetam (IRL790) in patients with Parkinson’s levodopa-induced dyskinesias (PD-LIDs) was expanded, as reported in July, to include 154 patients. In September, patient recruitment to the study was completed and top-line data is anticipated around the year-end.
• IRLAB’s partner Ipsen initiated clinical pharmacokinetic studies in September which are conducted in parallel with the IRLAB-sponsored Phase IIb study with mesdopetam. The IPSEN-led clinical studies are expected to be completed between Q3 2022 and Q1 2023 and will provide a standard set of data typically required for late-stage drug development and readiness for potential further studies with mesdopetam.
• IRLAB presented at several investor events to provide a business update of the company’s progress, e.g. at Pareto Securities, ABG Sundal Collier and ProHearings. Public recordings are available on the website, irlab.se.
• The share issue of 120,000 Class A shares relating to the acquisition of know-how related to the P003 discovery project was registered. After the registration, the total number of registered shares is 51,868,406 (51,748,406).

FINANCIAL HIGHLIGHTS IN THE THIRD QUARTER

• Net sales recorded: SEK 16.5m (SEK195.6m)
• Total operating expenses: SEK 40.4m (SEK 74.1m)
• The operational result: SEK -23.9m (SEK 121.7 m)
• Cash flow from operations: SEK -27.9m (SEK 202.8m)
• Cash and cash equivalents at the end of the period: SEK 291.7m (SEK 431.2m)
• 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 November 9, 2022, at 10:00 CET at the Infront Direkt Studio, Kungsgatan 33, in Stockholm. CEO Richard Godfrey, EVP and Head of R&D Nicholas Waters and CFO Viktor Siewertz will comment the interim report for the period January-September 2022. The presentation will be held in English and followed by a Q&A session, and available on demand on our website.

It is also possible to follow the presentation online on: https://youtu.be/3gMDBBbrTW4

COMMENTS FROM THE CEO
During my first full quarter at IRLAB, we have continued to make strong clinical progress in our lead programs and now look forward to several significant drug development milestones in the short and medium term. Building on our solid foundation, IRLAB’s portfolio of clinical, preclinical, and research projects to address the substantial unmet medical needs in Parkinson’s is progressing according to plan. Increasingly, this is drawing significant attention from the medical community and pharmaceutical industry. Talking to key opinion leaders, I find many share my belief that IRLAB’s portfolio of drug candidates could truly bring meaningful clinical benefit to people living with Parkinson’s.

Visibility and interest increasing
An important aspect of our current focus is to increase our presence and visibility within the scientific, medical, pharmaceutical, and investor communities. We have always been active but will increase our presence at both financial and scientific conferences such as Society for Neuroscience in San Diego in November and have also committed to play an active role in the International Conference on Alzheimer’s and Parkinson’s Disease, AD/PD, in March 2023, which this time takes place in our hometown Gothenburg, Sweden, where organizers are expecting over 4,700 participants. And with recent encouraging media coverage and our elevated presence in the investor communities both in Sweden and internationally, we see an uplift in our profile that will support our business and commercial development strategies.

Major portfolio milestones pending
Focusing on the portfolio, our Phase IIb study with mesdopetam in people living with Parkinson’s and levodopa-induced dyskinesias (PD-LIDs) has completed patient recruitment. We now anticipate the last patient in the study to complete their three-month treatment period in mid-December, after which the database will be locked and analyzed. Top-line results are anticipated around the turn of the year; this will be one of the biggest development milestones of the company to date. Together with our partner Ipsen, who has the exclusive worldwide rights to continue the development and commercialization of mesdopetam, we are very excited to receive the results of the study. Preparations are ongoing across several different workstreams to prepare for potential late-stage development and market readiness.

In conjunction with publication of this interim report, we will hold a broadcasted presentation where we will go through the Phase IIb study in more detail including a review of objectives, endpoints and what we are looking for in the top-line results.

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. We see that pirepemat has the potential to reduce falls frequency, resulting in fewer fall related injuries, improved patient quality of life, decreased stress for caregivers as well as lower economic burden on payors. The Phase IIb study is now recruiting late-stage Parkinson’s patients with mild cognitive impairment and increased falls frequency. The study objective is to evaluate pirepemat’s dose dependent efficacy on falls, cognitive function and neuropsychiatric assessments in addition to further building on the safety and tolerability database. This study is currently open at multiple sites in five European countries with patient recruitment actively continuing. At the moment, we anticipate to have the study fully recruited during the fall of 2023 and to report top-line results at the end of 2023.

Portfolio development ongoing
As we progress our research projects into development-stage assets, we are evolving our portfolio and company into a substantial clinical-stage biopharmaceutical business. IRL757 and IRL942 are being developed to address the non-motor function symptoms of Parkinson’s, apathy and cognitive impairment, respectively – and potentially wider patient populations in neurology. Both assets show promising preclinical efficacy and safety profiles and are progressing according to plan towards initiating Phase I clinical trials in 2023. Furthermore, our research project P003 aims to develop a completely novel, orally administered once-daily Parkinson’s treatment, without the troublesome complications of current standard-of-care or emerging treatments, is making encouraging progress toward CD nomination and the regulated development towards clinical trials.

Strong quarter and bright outlook
This quarter has been very productive for IRLAB, making solid progress in all programs. Acknowledging the challenging global economic and geopolitical situation we believe IRLAB is well placed, and we continue to evaluate options to strengthen our position further. The cash flow for the third quarter of 2022 was SEK –31 million; our balance sheet remains strong with a cash position of SEK 292 million at the end of the quarter. The next few months and indeed 2023 promises to be very exciting, as we anticipate top-line data from our mesdopetam study very soon and will also be in a position to provide updates on several other significant clinical milestones. Thank you for your continued support, as we continue to make solid progress to transform the treatment options for people living with Parkinson’s, and I look forward to speaking with you regularly as we progress our drug candidates through clinical development.

Richard Godfrey, CEO, IRLAB