IRLAB Therapeutics

SUMMARY OF THE FOURTH QUARTER

• A collaboration commenced with the US regulatory advisors Clintrex, guiding IRLAB’s US regulatory strategy, and ProPharma Group, IRLAB’s regulatory agent in the US. A request was prepared together for an end-of-Phase 2 meeting with the FDA where the Phase III program for mesdopetam will be defined. The request was submitted on December 18, 2023, and the FDA accepted and confirmed the meeting date to February 20, 2024.
• Capital markets day was held 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 the external opinion leader Karl Kieburtz. Recordings are available on IRLAB’s website, www.irlab.se.
• IRLAB was granted a new patent in Europe covering both a new salt of drug candidate pirepemat and the process for its preparation. This further strengthens the already strong patent protection for one of the company’s lead programs.
• At the end of the year, it was confirmed that drug candidate IRL757 has completed the preclinical studies and development work neccessary to start Phase I. The work collating information for the clinical trial application (CTA) is underway.
• IRLAB was granted over SEK 20 million in financing from The Michael J. Fox Foundation to support the development of IRL757 as a treatment for apathy in Parkinson’s. The grant will be used to conduct the first clinical study, a Phase I study, with IRL757.
• A loan agreement was entered on December 22, 2023, with Formue Nord Fokus A/S, increasing the company’s liquidity with up to SEK 55 million and extending the company’s financial runway and increasing business opportunities.
• The appointment for the company’s CEO Gunnar Olsson was extended.

EVENTS AFTER THE PERIOD

• The pioneering Phase II study React-PD of pirepemat has generated new insights about the specific Parkinson’s population the study is conducted in, individuals with high fall frequency, which enables data driven predictions that provides more accurate predictions about the study timeline. Based on these new insights, the study is anticipated to have completed patient recruitment during the third quarter of 2024.
• The company will participate at the medical conference AD/PD™ 2024: 18th International Conference on Alzheimer’s and Parkinson’s Diseases and related neurological disorders in Lisbon, Portugal, on March 5-8, 2024, with two poster presentations about drug candidates pirepemat and IRL1117, respectively.

FINANCIAL HIGHLIGHTS IN THE FOURTH QUARTER

• Net sales: SEK –1.2m (SEK 12.2m)
• Operating profit: SEK –35.7m (SEK –33.1m)
• Earnings per share before and after dilution: -0.67 SEK (-0.64 SEK)
• Cash and cash equivalents at the end of the period: SEK 111.3m (SEK 252.8m)
• Cash flow from operations: SEK –33.9m (SEK -37.9m)
• Share price at the end of period: 7.50 SEK (38.30 SEK)

Figures within brackets refer to the same period last year, unless otherwised stated.

PRESENTATION FOR 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://www.youtube.com/live/-LGAK3NHUP4?si=9xWvl9JvhGI6e_C3

COMMENTS FROM THE CEO
As 2023 comes to an end and I reflect on the company’s development over the year, I am pleased to report continued significant progress – in some respects beyond expectations – in our world-leading portfolio of innovative pharmaceutical projects, all of which have the potential to meet the great medical needs of people living with Parkinson’s disease and other neurological disorders. Significant events during the year include the identification of IRL1117 as a new drug candidate and that IRL757 has advanced to Phase I-ready status and receiving attention from The Michael J. Fox Foundation to conduct a Phase I study. In addition, we have secured an upcoming end-of-Phase 2 meeting with the FDA for the Phase III ready mesdopetam progam. Furthermore, the pioneering Phase IIb study with pirepemat has already generated new knowledge about the specific group of Parkinson’s patients living with recurrent falls. Those who participate in our study fall much more often than what has been previously published, which provides good conditions for capturing treatment effects. In addition, since May 2023, when all centers had been activated, we also have a clearer understanding of the patient recruitment pace, which in combination gives us the opportunity to make better estimates of the study duration.

“We have recently completed the compilation of a Briefing Package on mesdopetam as part of the preparations for the upcoming end-of-Phase 2 meeting with the FDA. The agency has confirmed a meeting with us scheduled for February 20. This is an important milestone towards finalizing the planning of Phase III for mesdopetam. In December, the highly respected The Michael J. Fox Foundation announced that it had decided to finance IRLAB and the company’s work with the substance IRL757 for the treatment of apathy with just over 2 million USD to conduct a clinical Phase I study. Both of these events are remarkable as they both constitute external validation and reinforce the quality of the research and development work that IRLAB conducts. I would also like to take this opportunity to give praise to all employees who have contributed to these acknowledgments from world-leading evaluators of pharmaceutical projects.”

IRLAB’s great advancements over the year are good news for individuals with Parkinson’s while also generating value for the company’s shareholders. During the fourth quarter of this year, our development programs continued as planned and new important milestones were reached, once again validating the quality of the research and development work within the company.

Mesdopetam – upcoming end-of-Phase 2  meeting with the FDA in February
After the new agreement with Ipsen was concluded, work began to transfer materials and information from Ipsen while compiling a briefing package for the end-of-Phase 2 meeting (EoP2) with the FDA. The purpose of the EoP2 meeting is to define the Phase III program and identify the path towards compiling a New Drug Application (NDA) – an application to market the drug. In mid- December, the company requested an EoP2 meeting, and the FDA subsequently accepted the application and announced that it will take place on February 20, 2024. The completed Phase IIb study showed both an anti-dyskinetic and an antiparkinson effect paired with a placebo-like safety and tolerability profile. Based on this, I believe that mesdopetam has the potential to become a first-line treatment for levodopainduced dyskinesias in Parkinson’s patients. Our external clinical experts and regulatory advisors share IRLAB’s view that mesdopetam’s profile provides conditions for both successful treatment and significant commercial potential.

Parallel to preparing for the EoP2, the work continues to secure the resources needed to conduct a Phase III program and later marketing of the product.

IRL757 – Robust external validation and  financing of our next clinical program
In December, we completed the preclinical development work that will form the basis for a regulatory application to start clinical development in Phase I for IRL757. The drug candidate is being developed to treat apathy, a condition seen in most neuro- degenerative diseases, where there are currently no effective therapies. Almost simultaneously, the esteemed American research organization The Michael J. Fox Foundation (MJFF) announced that it is awarding IRLAB a research grant of just over 2 million USD to advance the IRL757 project into the clinical phase. The grant will finance the project during 2024 and parts of 2025. This is a fantastic external validation of the quality of our research and development activities.

Our discussions with MSRD, a company within the Otsuka family, about a collaboration on the early clinical development of the substance are ongoing.

Ongoing Phase IIb study of pirepemat
The ongoing pioneering Phase IIb study with pirepemat has already generated new knowledge about the specific Parkinson’s population involved in the study. From baseline measurements before the double blind treatment period begins, it’s clear that the individuals fall more often than expected and that the fall frequency is stable during the one-month observation time. Since May 2023, when all centers had become active, we have a clearer view of the patient recruitment pace, which gives us the opportunity to make more accurate and data driven estimates, based on information that was not available at the start of the study. Combined, this means that we now expect the study to have completed recruitment in Q3 2024, which is later than previous estimates. This is balanced by the positive effects of the increased understanding of the patients and their fall frequency, which provide a greater possibility to detect a treatment effect.

From treating physicians we hear that patients give positive reviews of the study and we have received several requests to continue treatment after study completion, i.e., signals of perceived benefits of participating in the study.

Based on what we now know about pirepemat, I see a great opportunity to create a first-in-class treatment for the biggest medical need in Parkinson’s – to reduce and prevent falls and fall injuries. This also implies significant commercial potential for pirepemat since there is no available treatment today to reduce the risk of falls and the costs that fall injuries entail. The newly approved patent that we reported in December further strengthens pirepemat’s position.

Preclinical programs with potential  to address major medical needs
Our drug candidates in the preclinical development phase are progressing according to plans to be ready to enter clinical Phase I studies – IRL942 for improving cognitive impairment in Parkinson’s and other neurological diseases, and IRL1117 for treating the basic symptoms of Parkinson’s (tremor/shaking, stiffness, and bradykinesia/slow movements) without causing the troublesome complications associated with current levodopa- based treatments. A drug with this profile has the potential to replace levodopa and thus represent a paradigm shift in the treatment of Parkinson’s.

Forward-looking
We have a world-leading portfolio of drug candidates for treating Parkinson’s and other neurological diseases. Within the next 12–18 months, we have the potential to reach several value generating inflection points:

• Mesdopetam: Positive outcome at the end-of-Phase 2 meeting with the FDA; Partnership for driving Phase III and commercialization
• Pirepemat: Completion of the ongoing Phase IIb study; Partnership for driving Phase III and commercialization
• IRL757: Transition to clinical phase through the start of a Phase I study during H1 2024. Partnership for early development collaboration
• IRL942: Transition to clinical phase. Partnership for early development collaboration
• IRL1117: Transition to clinical phase

To reach these potential inflection points, we are focused on securing financing for our activities. The financing from MJFF and the loan agreement with Formue Nord are a couple of initial steps. Intense ongoing business development activities focused on mesdopetam and IRL757/942 gives further opportunities, as do discussions with the capital market. These activities are driven, among other things, through participation in partnering meetings, such as BioEurope Fall in Munich in November, where about thirty meetings were held with other companies. Follow-up discussions are ongoing, and we are planning for additional meetings during spring and summer. I feel that both the upcoming EoP2 meeting with the FDA regarding mesdopetam and the financing from MJFF have strengthened our position for positive outcomes.

I look forward to continuing to develop the company and the exciting portfolio of drug candidates together with our employees and board. Finally, I would like to express my gratitude to all employees who have contributed to the past year’s progress, and to all shareholders for the support and trust you have given us.