IRLAB publishes interim report for the period January-September 2023

SUMMARY OF THE THIRD QUARTER

• In July, the Data Safety Monitoring Board (DSMB) unanimously recommended to continue the ongoing Phase IIb study of pirepemat in accordance with the approved study protocol following a planned review of the first 25 patients having completed the study.
• The full ownership of the now Phase III-ready mesdopetam project was secured by IRLAB in August. Simultaneously, IRLAB confirmed its intention of continuing with development of mesdopetam to Phase III.
• An in-depth analysis of the Phase IIb study show that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect in combination with a tolerability and safety profile on par with placebo, giving mesdopetam a unique position. The results were presented at the end of August at the MDS Congress in Copenhagen.
• IRLAB has participated at several national investor conferences and has ongoing discussions with national and international investors. Recordings are available on IRLAB’s website, irlab.se.

EVENTS AFTER THE END OF THE PERIOD

• In October, a collaboration commenced with the US regulatory advisors Clintrex, who lead IRLAB’s US regulatory strategy, and ProPharma Group, who has been contracted as IRLAB’s regulatory agent in the US. Together, preparations for an end-of-Phase 2 meeting with the FDA where the Phase III program for mesdopetam will be defined are now underway.
• IRLAB held a capital markets day on October 17 where investors, analysts and financial media were updated on the company’s drug development portfolio and growth strategy. Presentations were held by company representatives as well as an external opinion leader and a recording is available on IRLAB’s website, irlab.se.

FINANCIAL OVERVIEW IN THE THIRD QUARTER

• Net sales: – (SEK 16.5m)
• Operating profit: SEK –40.7m (SEK –23.9m)
• Earnings per share before and after dilution: -0.74 SEK (-0.46 SEK)
• Cash and cash equivalents at the end of the period: SEK 118.8m (SEK 291.7m)
• Cash flow from operations: SEK –36.7m (SEK -27.9m)
• Share price at the end of period: 7.38 SEK (34.5 SEK)

Figures in brackets = same period 2022, unless otherwise stated

PRESENTATION TO INVESTORS AND MEDIA

Wednesday, October 25, 2023, at kl. 10.00 CEST is the presentation of the Q3 interim report through a digital webcast. The presentation will be held in English and followed by a Q&A session.

Access via link: https://youtube.com/live/6D1RmKaQ6dc

COMMENTS FROM THE CEO
During the third quarter of this year, our development programs continued according to plan and important milestones were achieved. IRLAB continues to make significant progress in developing innovative drugs for Parkinson’s and other neurological disorders.

“We recently conducted a highly appreciated capital markets day where we had the opportunity to convey a deeper understanding of our business, showcase the commercial potential of our development portfolio, and provide an update on the status of our projects. Professor Karl Kieburtz, a thought leader and regulatory expert, outlined the upcoming crucial interactions with the FDA in preparation for mesdopetam’s Phase III program. I believe this contained news for many regarding the extent of the requirements for a thorough Briefing Book to address any questions the FDA may pose. You only get one chance, so it is crucial that it is done well and right – I am pleased to have Karl and his competent team guiding us in this endeavor. If you missed our capital markets day, I recommend watching it afterward – a link is available on our website.”

Significant strengthening of our world-leading portfolio in Parkinson’s
By utilizing our proprietary and unique research platform – ISP, we have built a world-leading portfolio of drug projects focused on unmet needs in Parkinson’s. The portfolio includes completely new treatments based on novel mechanism of actions, that can address the majority of complications and symptoms across all stages of the disease while simultaneously generating value for our shareholders. Following the recent securing of the ownership of mesdopetam, we have further strengthened our position. The portfolio projects now span from preclinical to Phase III readiness. Over the next 1-2 years, we could have up to five drug candidates in clinical development Phase I-III – an impressive and achievable company development.

With the new agreement signed with Ipsen on August 21, where we secured ownership and all rights to the mesdopetam project, our portfolio of drug projects has been further strengthened. The transfer of all data and materials developed by Ipsen, from Ipsen to IRLAB, is ongoing and should be completed by the end of October.

Mesdopetam – a drug candidate with both anti-dyskinetic and anti-Parkinsonian effects
Following the new agreement with Ipsen, we have been able to communicate the results from the completed Phase IIb study with mesdopetam in patients with levodopa-induced dyskinesia. The results can be summarized briefly as follows: mesdopetam demonstrates both dose-dependent anti-dyskinetic and dose-dependent anti-Parkinsonian effects, along with a safety and tolerability profile comparable to placebo. There is currently no other medication with this combination of effects. We have also been able to discuss the results of the Phase I studies conducted by Ipsen, which confirm mesdopetam’s predictive pharmacokinetic profile. This allows for the inclusion of a broad population of patients with levodopa-induced dyskinesia in the upcoming Phase III program, which will facilitate the execution of future clinical studies. It will also be reflected in the product label, which is crucial to ensure that treatment can be given to a broad patient group.

Planning for the end-of-Phase 2 meeting with the FDA
We have now partnered with Clintrex and ProPharma, two world-leading US-based regulatory advisory companies. This collaboration serves two purposes: firstly, to compile the necessary documentation for the end-of-Phase 2 meeting (EoP2) with the US FDA, and secondly, to provide support in conducting the EoP2 meeting. We will request an EoP2 meeting as soon as a Briefing Book containing all available information has been compiled. The purpose of the meeting is to define the design of a Phase III program and the path to preparing a marketing authorization application for mesdopetam. Our external clinical experts and regulatory advisors share IRLAB’s view that mesdopetam’s profile provides the potential for both successful Parkinson’s treatment and significant commercial opportunity.

Ongoing Phase IIb study of pirepemat
In the ongoing Phase IIb study of pirepemat, the efficacy, safety, and tolerability of two doses of pirepemat are evaluated in people living with Parkinson’s disease in order to identify the optimal dose for Phase III. In mid-July, the first planned DSMB review took place following the first 25 patients having completed the study. The DSMB unanimously recommended the study to continue according to plan.

For the study’s execution, we are collaborating with a Contract Research Organization (CRO), which manages the various aspects of the study based on our study protocol. The recruitment rate has been slower than planned during the fall, and our assessment is that patient recruitment will need to continue into the first quarter of 2024. Together with our advisors, we are evaluating measures to ensure that top-line results can still be reported in the second quarter of 2024, consistent with previous communication.

Preclinical programs with potential to address major medical needs
Our drug candidates in the preclinical development phase are progressing according to plans to be made ready for entering into clinical Phase I trials. IRL757 aims to treat apathy in Parkinson’s and other neurological disorders, and IRL942 targets the improvement of cognitive impairment in people with Parkinson’s and other neurological disorders. Our discussions with MSRD, a company within the Otsuka family, around a potential collaboration for these two projects are ongoing.

Our IRL1117 project has the objective to develop a treatment for the hallmark symptoms of Parkinson’s (tremors, stiffness, and bradykinesia) without causing the troublesome complications associated with current mainstay levodopa-based treatments. A drug with this profile has the potential to replace levodopa and therefore bring a paradigm shift to the treatment for Parkinson’s.

Forward-looking
In the beginning of 2023, we defined priorities for the year. After the mesdopetam project transfer to IRLAB, we have now reviewed our internal priorities to optimally support our product development activities. This includes evaluations of the best way to finance the further development of our assets – through licensing/collaboration agreements and/or through the capital market.

Our most important priorities are:

• Mesdopetam: Rapid transfer of the project to IRLAB; conduct the EoP2 meeting with the FDA; assess options and secure funding for Phase III activities.
• Pirepemat: Complete the ongoing Phase IIb study.
• Preclinical projects: Execute select activities aimed at supporting the establishment of partnerships for development.
• Evaluate possible avenues for financing the company’s future activities.

To secure financing moving forward, a comprehensive effort is being carried out in Business Development (BD) to explore partnership opportunities and, thereby, funding. Ongoing discussions are underway regarding a new licensing agreement for mesdopetam and a research collaboration involving IRL757 and/or IRL942. Simultaneously, discussions with financial market stakeholders are taking place. These activities are aimed to secure funding for activities related to our projects after the first half of 2024. We believe that the strengthening of our project portfolio with the Phase III-ready mesdopetam project has enhanced our potential to establish collaborations and secure funding for our projects. We continue to monitor our financial stability diligently and assess our opportunities continuously.

I am looking forward to continuing the development of the company and the exciting portfolio of drug candidates together with our employees and the Board. We recently held an appreciated capital markets day where we provided a comprehensive overview of the company. If you missed it, the recording is available on our website.

Finally, I would like to express my gratitude to all shareholders for the support and trust you have bestowed upon us.

Gunnar Olsson, CEO, IRLAB