IRLAB Therapeutics

KEY HIGHLIGHTS DURING AND AFTER THE PERIOD

• Collaboration with MSRD/Otsuka, funding IRL757 through clinical Proof-of-Concept.
• Successful End-of-Phase 2-meeting with FDA for mesdopetam.
• New insights from the Phase IIb study with pirepemat.
• Regulatory approval to start Phase I with IRL757.
• Kristina Torfgård appointed CEO, starting August 1, 2024.
• Pirepemat passed the independent Data Safety Monitoring Board (DSMB) conducted the last of two predetermined reviews of safety and data integrity in the Phase IIb study, React-PD. The DSMB unanimously recommended that the study should continue without any changes.

FINANCIAL OVERVIEW OF THE SECOND QUARTER

• Net sales: SEK 42.8m (SEK 6.9m)
• Operating profit: SEK –5.1m (SEK –44.8m)
• Earnings per share before and after dilution: SEK -0.14 (SEK -0.87)
• Cash and cash equivalents at the end of the period: SEK 98.3m (SEK 156.4m)
• Cash flow from operations: SEK –0.1m (SEK -52.8m)
• Share price at the end of period: SEK 13.25 (SEK 8.66)

Figures in brackets = same period 2023, unless otherwise stated.

PRESENTATION TO INVESTORS AND MEDIA
Wednesday, May 8, 2024, at kl. 10.00 CEST a presentation of the Q1 interim report will be held through a digital webcast. The presentation will be held in English, followed by a Q&A session.
Access via link: https://www.youtube.com/live/MikgERaXqgY?si=pkoI-inxbEyOx96D

CEO COMMENT
The positive development at the beginning of the year continues and the second quarter has been very eventful with several important advances. We have started our phase I study with IRL757, entered into a collaboration with MSRD/Otsuka regarding the continued clinical development through clinical Proof-of-Concept, received the DSMB’s unanimous recommendation to continue the React-PD study with pirepemat in accordance with plan, and recruited a new CEO for the company.
 
The clinical program with IRL757 started
The extensive research support granted by MJFF and the collaboration agreement we have signed with MSDR/Otsuka validates the quality and level of innovation of our research and shows that world-leading external assessors share our confidence in the potential of IRL757 to treat apathy, a medical condition characterized by indifference that currently has no treatment and affects millions of individuals with neurodegenerative disorders and their relatives. 

At the end of May, shortly after we received approval from the Swedish Medicines Agency, we started our first Phase I clinical study with IRL757. The Phase I study is fully funded by the world’s largest non-profit funder of Parkinson’s research, The Michael J. Fox Foundation (MJFF) in the USA.

In May, we held a first joint steering committee meeting in our collaboration with MSDR/Otsuka where we began planning for the continued clinical development of IRL757 as a treatment for apathy. As we communicated previously, the agreement has a large financial value, in addition to upfront and milestone payments totaling $8.5 million, MSDR will cover all development costs all the way through Proof-of-Concept while IRLAB will carry out all activities and retain the product and patent rights. After the agreed development program is completed, MSRD/Otsuka has the option to negotiate a new agreement for extended partnership around ILR757. Based on industry standards, development costs to take a project from the start of Phase I and through Proof-of-Concept are estimated at approximately $25 million.
 
Financing during the quarter
The grant from the Michael J Fox Foundation for the implementation of the Phase I study with IRL757, as well as the agreement with MSDR/Otsuka for the continued clinical development of the drug candidate, has strengthened our cash position and secured full funding of our third clinical project (IRL757) through clinical Proof-of - Concept. In addition to this, we have also chosen to use the last tranche of SEK 25 million in the loan agreement with Fenja Capital in order to strengthen our resources for the other development projects. We are continuously working to strengthen our finances as access to capital is an important prerequisite to being able to achieve the value-creating milestones that we expect in our portfolio over the next 12–18 months.
 
Recruitment for React-PD soon completed
Our phase 2b clinical study React-PD, which evaluates the effect of pirepemat on the frequency of falls in Parkinson’s patients, is proceeding according to plan. As previously communicated, in the baseline measurements we recorded a clearly higher fall frequency in the group as a whole and a fall frequency at the individual level that was more stable than expected. In addition, more patients than we estimated chose to complete the study (lower drop-out rate). The combination of these parameters means that the possibility of detecting treatment effects in the study increases, which makes it possible to achieve the purpose of the study even with a lower number of patients, without the statistical power of the study being affected.

Based on this insight, we started discussions with the pharmaceutical authorities in the countries involved about the possibility of reducing the size of the study. This turned out well and we received uniform support in all countries where the study is carried out. As a result, patient recruitment to React-PD will be possible to complete in the third quarter of 2024. This will then be followed by a month-long baseline period, three-month treatment period, follow-up visits, data management, database lock, and analysis of study endpoints before top-line data can be reported. 

At the end of June, the independent DSMB (Data Safety Monitoring Board) conducted the last of two predetermined reviews of safety and data integrity in the React study. The DSMB unanimously recommended that the study should continue without any changes until the conclusion of the study.
 
Mesdopetam
Our preparations to be able to start the Phase III program for the treatment of levodopa-induced dyskinesias continue. During the past quarter, we have had a major focus on partner discussions, preparations for interactions with European regulatory authorities before the start of Phase III, as well as market research as part of positioning for a future launch of the product.
 
Kristina Torfgård new CEO from 1 August
In mid-May, IRLAB’s board recruited Kristina Torfgård as the company’s new CEO. Kristina Torfgård has over 30 years of experience from leading roles in the pharmaceutical and biopharma industry with solid knowledge and she has a large network in neurodegenerative diseases, most recently as CEO of the listed biopharma company Alzinova. I welcome Kristina to IRLAB and I look forward to collaborating and supporting her from my position as a board member of IRLAB.
 
Additional presentations and an unwavering focus
During the quarter, we presented IRLAB and our unique project portfolio in several investor meetings. Among other things, we have participated in Redeye Growth Day, ABGSC Investor Days and Stora Aktiedagarna where we presented the recent progress and our plans going forward. After a very successful first six months, we continue the journey forward with an unwavering focus on our innovative portfolio projects, all of which have the potential to become first-in-class drugs and revolutionize the treatment of Parkinson’s disease.

This is my last quarterly report as CEO and I would therefore like to take the opportunity to thank all shareholders for the trust you have placed in me during my time as CEO of the company. I would also like to thank all employees for the fantastic work that has been done and led to all the successes in the project portfolio in the past year. I look forward to continuing to work on the company’s board and being active in the development and capitalization of all our pioneering pharmaceutical projects.