SUMMARY OF THE SECOND QUARTER

• The management team strengthened by appointing Richard Godfrey as new CEO and Nicholas Waters as Executive Vice President and Head of Research & Development, effective July 1, 2022.
• Know-how acquired to support a strong patent application for chemical matter claims related to the P003 research project. The P003 project aims to offer a once-daily Parkinson’s treatment without the troublesome complications associated with chronic levodopa treatment.
• IRLAB presented at several investor events during the period to communicate updates of the company’s strategy and pipeline. Public recordings are available on the website, irlab.se.
• Viktor Siewertz, CFO, was a guest speaker at the Expert session at the BioStock Life Science Summit 2022, talking about the licensing agreement with Ipsen (one of the larger in the Swedish biotech space in decades).

AFTER END OF PERIOD

• The Phase IIb PD-LIDs study with mesdopetam has been expanded to include 154 patients, top-line data is anticipated around year-end.
• 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 SECOND QUARTER

• Net sales recorded in Q2 SEK 23.4m (SEK0m)
• Total operating expenses during the quarter SEK 50,6m (SEK 26.5m)
• The operational loss for the quarter SEK -27.1m (SEK -26.6m)
• Cash flow from operations SEK -44.0m (SEK -23.4m)
• Cash and cash equivalents amounted to SEK 322.6m 2022 (SEK 229.4m)
• The total number of registered shares 51,748,406 (51,748,406)

Figures in brackets = same period 2021, unless otherwise stated

PRESENTATION TO INVESTORS AND MEDIA
A presentation will be held on August 24, 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-June 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/NHxs1EViwIM

COMMENTS FROM THE CEO
I am delighted to provide an update on IRLAB’s progress over the last quarter, my first update since joining the Company as CEO on July 1, 2022. I am grateful for the warm welcome I have received, and during the summer I have been working with Nicholas Waters, the senior management team, and the Board to get up to speed and take a deep dive into the business.

My first impressions are very encouraging, and now having had a chance to examine our data and speak candidly with some of our patient-facing clinical team, I am even more optimistic that our pipeline of drug candidates will bring meaningful benefit to patients with Parkinson’s.

In my initial consideration of IRLAB, my analysis highlighted some very compelling strategic rationales that provide the foundation of our strong business case.

Firstly, our R&D pipeline of drug candidates is strategically designed and focused to address patients’ needs during their Parkinson’s journey, offering chronic symptomatic relief from the most troublesome of Parkinson’s symptoms including dyskinesias, trips and falls, apathy and psychosis. Not only does this meet the severe unmet medical needs for the millions of patients living with Parkinson’s, it also represents a very attractive pharmaceutical business case.

Secondly, our Phase IIa proof-of-concept data for mesdopetam and pirepemat provides encouraging safety and efficacy signals in Parkinson’s patients.

Thirdly, our global license with Ipsen to develop and commercialize mesdopetam is a strong clinical and commercial validation of our business.

And of course, last, but not least, is our deep and profound understanding of the biology of Parkinson’s and other CNS disorders rooted in the Nobel Prize-winning research of Prof. Arvid Carlsson and his research group. This knowledge and expertise are harnessed in our proprietary ISP drug discovery platform that can discover truly unique drug candidate molecules with unique neuropharmacological activity to address the disease biology.

Going forward, I will concentrate on the strategic commercial, business development and financing aspects of IRLAB; and Nicholas Waters in his new role as EVP and Head of R&D will focus on the delivery of our pipeline programs. My priorities are to increase the awareness and visibility of IRLAB and our pipeline programs both in the Nordics and internationally and to focus our messaging on the potential significant patient benefits that our drug candidates offer to different stakeholders.

I have also been impressed with the way in which IRLAB has remained focused during the Covid-19 pandemic and its associated challenges. Solid progress was made during the second quarter in our Phase IIb clinical trial with mesdopetam in PD-LIDs. Levodopa-induced dyskinesias (LIDs) is a severely limiting treatment-related symptom affecting 30 percent of Parkinson’s patients. We saw an uptick in the recruitment into the study and recently announced that we, in collaboration with Ipsen, have expanded the study from 140 to 154 patients and have opened additional sites in the US and Poland. It is most encouraging that interest in the study have remained high and consistent among investigators and patients given the imposed restrictions in many regions due to Covid-19. We look forward to reporting top-line data around year-end.

Also during the quarter, in our Phase IIb, randomized and placebo-controlled study evaluating efficacy of pirepemat on falls frequency in Parkinson’s patients, we continued to activate sites across Europe and screened and enrolled patients. We aim to report top-line data by the end of 2023.

The cash flow for the second quarter of 2022 was SEK –45 million; our balance sheet remains strong with a cash position of SEK 323 million at the end of the quarter.

In summary, I believe we are very well positioned as a biotech business with late-stage clinical assets, commercial validation and a strong pipeline – and increased awareness should deliver value growth to you, our shareholders. I look forward to meeting as many of you as possible at one or more of the several upcoming events during the fall such as the Q2 presentation and investor events. Do follow us on LinkedIn and check the website to keep updated on our events and activities.

Richard Godfrey, CEO, IRLAB