IRLAB publishes interim report for the period January-June 2023

SUMMARY OF THE SECOND QUARTER

• On May 3, IRLAB became aware that Ipsen’s Universal Registration Document 2022, published on April 6, 2023, contained the incorrect information that the development and commercialization rights for mesdopetam had been transferred back to IRLAB. This error was corrected by Ipsen, who published an updated Universal Registration Document 2022.
• During May 2023, a discussion was initiated with Ipsen to mutually agree on the best way forward to ensure that the mesdopetam program are given the best chance of achieving registration and to ensure that mesdopetam can be made available to all people living with Parkinson’s disease.
• On May 16, IRLAB and the McQuade Center for Strategic Research and Development (MSRD), part of the global pharmaceutical company Otsuka, signed an agreement that gives MSRD an exclusive right to evaluate, for a period of time, IRLAB’s neuropsychiatric programs IRL757 and IRL942. The objective is to investigate whether IRLAB and MSRD, after the evaluation, can agree to enter into a collaboration to develop the compounds into medicines.
• At the end of May, it was announced that all 38 clinics are activated and recruits patients in the Phase IIb study with pirepemat. Pirepemat is developed with the goal of improving balance and reducing falls in Parkinson’s disease.
• On June 13–16, IRLAB participated with a presentation at the scientific conference XIV Triennial Meeting of the International Basal Ganglia Society (IBAGS) held in Stockholm. IBAGS XIV is a major event that brings together researchers who study the basal ganglia of the brain at all levels (from molecule to behavior) in both neurological and neuropsychiatric disorders originating in the basal ganglia that also include Parkinson’s disease.
• On June 20, the company’s annual general meeting was held where, among other things, three new members were elected to the board; Daniel Johnsson, Christer Nordstedt and Veronica Wallin.
• IRLAB presented at several national investor conferences during the period and has ongoing discussions with potential national and international investors to continuously provide updates on the company and its development. Recordings are available on IRLAB’s website, irlab.se.

EVENTS AFTER THE END OF THE PERIOD

• In mid-July, the DSMB for the pirepemat Phase IIb study unanimously recommended the company to continue the study in accordance with the approved study protocol, following their first planned review. The DSMB continuously reviews the clinical study data generated during an ongoing study. This is to ensure the safety of study participants and the validity and integrity of data. This scheduled review was performed after the first 25 patients had completed the entire treatment and follow-up period of the study.
• On August 21, the company announced that the rights to the now Phase III-ready mesdopetam project had been transferred to IRLAB. IRLAB has secured the ownership of the mesdopetam project. This includes, among other things, all technology, all rights, know-how, intellectual property and study drugs for upcoming Phase III studies. IRLAB will also control continued clinical development and commercialization. As compensation, IRLAB pays a low single digit royalty based on future product sales, to Ipsen.
• On August 21, IRLAB communicated an update of the mesdopetam project, which included additional information on the results of mesdopetam’s Phase IIb clinical trial in PD-LIDs and the Phase III preparatory Phase I studies conducted by Ipsen. The results 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 from the extensive data package developed by IRLAB and Ipsen provides a strong basis for the continued development of mesdopetam to Phase III. IRLAB now continue with preparations for Phase III by compiling documentation for an end-of-Phase 2 meeting with the US FDA to define the Phase III study program.
• During the MDS congress, held August 25-28, IRLAB presented further results from the analyses of the Phase IIb study with mesdopetam. The scientific poster is available at irlab.se.

FINANCIAL HIGHLIGHTS IN THE FIRST QUARTER

• Net sales recorded: SEK 6.9m (SEK 23.4m)
• Total operating expenses: SEK 51.7m (SEK 50.6m)
• The operating result: SEK –44.9m (SEK –27.0m)
• Cash flow from operations: SEK –52.8m (SEK -44.0m)
• Cash and cash equivalents at the end of the period: SEK 156.4m (SEK 322.6m)
• 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 August 30, 2023, at 10:00 CEST 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-June 2023. The presentation will be held in English and followed by a Q&A session.

Follow the presentation online on:
https://youtube.com/live/tmtQrel7r_s

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 second quarter of this year, we achieved important milestones in our development programs. After the period, on August 21, IRLAB secured the full ownership of the now phase III ready mesdopetam project. Our broad and world-leading project portfolio in Parkinson´s disease addresses the great majority of complications and symptoms that the person living with Parkinson may experience after diagnosis and during the continued progression of the condition. We remain confident in the potential of our portfolio of drug candidates to address the unmet medical needs for those living with Parkinson’s and other CNS diseases.

Building a 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, and which could simultaneously generate 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 preparation stage products. Over the next 1-2 years, we could have up to five drug candidates in clinical development phase I-III – an impressive and highly possible development of the company.

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. One of the key aims for the study was to evaluate dose-response relationship for mesdopetam in order to be able to determine the appropriate dose for Phase III. Following a comprehensive analysis of all data we have concluded that mesdopetam has a dose-dependent anti-dyskinetic and anti-parkinsonian effect without compromising normal motor function coupled with a safety and tolerability profile on par with placebo for all doses tested. Based on the results of the phase IIb study, the dose 7.5 mg twice daily is the preferred dose to be investigated in Phase III. An update of the mesdopetam project was communicated on a webcast on the 22nd of August and can be viewed here. A comprehensive analysis of the Phase IIb study data was presented at the International Congress of Parkinson´s Disease and Movement Disorders, MDS Congress, in Copenhagen on August 28.

Securing ownership of mesdopetam and Planning for end-of-Phase 2 meeting with the FDA
Following a contact by Ipsen on May 1, discussions between Ipsen and IRLAB were initiated on the best way forward for mesdopetam in order to reach the market and become available for patients in need. These discussions were concluded on August 21, resulting in IRLAB securing all rights and full ownership of mesdopetam. We will now pursue the regulatory path toward Phase III and request an end-of-Phase 2 meeting with the FDA as soon as a briefing book including all available information has been compiled. The purpose with the meeting is to define the design of a Phase III program for mesdopetam. Ipsen will support us in the preparation of the briefing book. In parallel, we will evaluate options for the execution of Phase III. External key opinion leaders and advisors share IRLAB´s view that the profile of mesdopetam provides both the prerequisites for a successful treatment in Parkinson’s and that it has a significant commercial potential.

With the new agreement, IRLAB has full ownership of all data generated by Ipsen, including the three Phase I clinical studies performed during 2022 and 2023, CMC development, and manufactured drug product for a Phase III program. The full transfer of the project to IRLAB will be completed during the fall 2023.

Ongoing Phase IIb study of pirepemat
In the ongoing Phase IIb study with 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. By the latter part of May all participating clinics were activated. By mid-July, the first planned DSMB review took place following 25 patients having completed the study. The DSMB unanimously recommended the study to continue according to plan. Recruitment of patients has been slightly slower than anticipated and actions are being taken to facilitate patient recruitment with the aim to complete recruitment by the end of 2023, followed by a three-month treatment period. Based on the current timeline estimate, top-line results are expected in H1 2024.

In previous interactions with the FDA, IRLAB was advised to frontload the development plan for pirepemat with preclinical in vivo as well as specific in vitro studies. This, as a result of the transient liver enzyme elevations observed in a few subjects in early clinical studies. The frontloaded preclinical studies have been performed with no sign of new previously undetected metabolites of pirepemat, nor negative effects on liver cells by pirepemat or its metabolites.

Preclinical programs has potential to address major 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 dysfunction in people with Parkinson’s and other neurological disorders. Key ongoing activities for these projects include CMC development and IND/CTA enabling studies with the aim to have a formulation of the compound ready for human dosing, as well as having demonstrated safety for the dose levels to be used in Phase I. Reassuringly, no unexpected findings have been observed, and we anticipate to reach the Phase I ready stage as previously communicated.

On May 16, an agreement was signed with MSRD, a company within the Otsuka family, giving MSRD the exclusive right to evaluate IRL757 and IRL942 for a potential drug development collaboration for the two neuropsychiatric projects.

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 effect fluctuations 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. The project continues according to plan.

Forward-looking
In the beginning of 2023, we defined priorities for the year. With the mesdopetam project transfer to IRLAB, we will review 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. We anticipate that the strengthening of our project portfolio with the Phase III ready mesdopetam program will improve our partnering and financing opportunities to advance our world-leading portfolio of treatments in Parkinson´s disease. We remain vigilant on our financial stability as we continuously evaluate our opportunities.

I am looking forward to continuing to develop the company and the exciting portfolio of 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