Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q1 2023 Earnings Presentation
36 slides from Irlab Therapeutics Ab Class A's earnings presentation, May 1, 2023
Slide 1: Transforming life for people living with Parkinson's
Transforming life for people living with Parkinson’s Q1 2023 Gunnar Olsson, CEO Nicholas Waters, EVP and Head of R&D Viktor Siewertz, CFO
Slide 2: Disclaimer
Disclaimer This document, “IRLAB Therapeutics” (the “Presentation”), has been prepared by IRLAB Therapeutics AB (publ) (“IRLAB”) and is provided for informational purposes only. All information in this Presentation has been compiled in good faith by IRLAB. Neither IRLAB nor any of its directors, emp
Slide 3: Today's agenda
Q4 business Today’s agenda update 1 News in the period 4 Concluding words 2 R&D update 3 Financials 5 Q&A session 3
Slide 4: Operational highlights in the first quarter
Q1 update Operational highlights in the first quarter • IRLAB participated at the 6th Neuroscience Innovation Forum hosted by Sachs Associates in early January, held in connection to the Annual J.P. Morgan Healthcare Conference, in San Francisco, US • IRL1117 was nominated development candidate from
Slide 5: Operational highlights in the first quarter
Q1 update Operational highlights in the first quarter • Top-line results from the Phase IIb study of mesdopetam in people with Parkinson’s disease levodopa- induced dyskinesias (PD-LIDs) were announced in mid-January. • While the study did not reach statistical significance in the primary endpoint,
Slide 6: Operational highlights in the first quarter
Q1 update Operational highlights in the first quarter • In mid-February, the company announced an update to the portfolio development milestones following an assessment of the operational priorities for 2023 • On February 20, Dr Gunnar Olsson, M.D., Ph.D was appointed as interim CEO following Richar
Slide 7: Operational highlights in the first quarter
Q1 update Operational highlights in the first quarter • At the end of March, IRLAB presented new data related to the preclinical drug candidates IRL942 , IRL757 and the ISP platform in an oral presentation and in three poster presentations at the International Conference on Alzheimer’s and Parkinson
Slide 8: Operational events after end of period
Q1 update Operational events after end of period • On May 3, IRLAB was made aware that Ipsen’s 2022 Universal Registration Document (URD), published on April 6, 2023, contains the incorrect information that the development and commercialization rights for mesdopetam have been transferred back to IRL
Slide 9: Financial highlights in the first quarter
Q1 update Financial highlights in the first quarter • Net sales recorded: SEK 0 (SEK 9.0m) • Total operating expenses: SEK 59.5m (SEK 38.2m) • The operating result: SEK –59.5m (SEK –29.1m) • Cash flow from operations: SEK –41.5m (SEK -28.4m) • Cash and cash equivalents at the end of the period: SEK
Slide 10: IRLAB – at a glance
IRLAB – at a glance Organization Pioneering Validated proof- Broad & Solid Focused strategy positioned for biology & ISP of-concept portfolio success Deep profound Discover and From discovery Five unique drug Experienced understanding of develop through Phase II candidates each international Parkins
Slide 11: Parkinson's disease
Parkinson’s disease Parkinson’s disease What happens? Loss of >50% cells in the brain that produce dopamine Why is that important? Dopamine is one of the most important signaling substances in the brain. Controlling emotions, thoughts and movements (motor functions) Why does it happen? Age is the mo
Slide 12: The most bothersome symptoms according to people with Parkinson's
The most bothersome symptoms according to people with Parkinson’s What bothers people the most with Parkinson’s disease? Self-reported, n=25 000 25 000 people with Parkinson’s reported about their illness through the instrument PROP, part of the Fox Insight project led by the Michael J. Fox Foundati
Slide 13: IRLAB to address top priorities for management of Parkinson's
Parkinson’s and IRLAB to address top priorities for IRLAB’s solutions management of Parkinson’s Parkinson’s is one of the fastest growing CNS disorders 2040 IRLAB’s drug candidates are aimed to address the full disease progression 12.9 million Identified treatment priorities2 IRLAB’s portfolio diagn
Slide 14: Pipeline generated with our unique proprietary drug discovery platform - ISP
ISP Pipeline generated with our unique proprietary drug discovery platform - ISP Integrative Screening Process (ISP) • Advanced systems biology approach • Drug design informed by machine learning techniques • ISP predicts drug candidates with greatest benefit potential and lowest toxicity risk, base
Slide 15: Living with Parkinson's: IRLAB transforms the treatment algorithm
Parkinson’s and Living with Parkinson’s: IRLAB’s solutions IRLAB transforms the treatment algorithm Prior to diagnosis Parkinson’s diagnosis IRLAB’s solution Objective Early-stage Advanced/late-stage Balance/falls Speech/swallowing Freezing of difficulties Pirepemat No more falls gait Cognitive Prom
Slide 16: Mesdopetam (IRL790)
Mesdopetam (IRL790) ( mes⏝dop⏝e⏝tam ) • Mesdopetam counteracts levodopa-induced dyskinesias (PD-LIDs) by a novel mechanism inhibiting dopamine D3 receptors • Potential treatment and prevention of psychosis in Parkinson’s (PD-P) • Ipsen licensed the exclusive global rights to develop and commercializ
Slide 17: Growing body of clinical evidence supporting a novel treatment of dyskinesia in PD
Mesdopetam Growing body of clinical evidence supporting a novel treatment of dyskinesia in PD Clinical studies of mesdopetam Phase I: SAD Phase Ib Phase IIa Phase IIb Pivotal studies PD-LIDs* +MAD PD-LIDs* PD-LIDs PD-LIDs Phase II PD-Psychosis* • Well tolerated • Well tolerated • Mesdopetam treatmen
Slide 18: Pirepemat (IRL752)
Pirepemat (IRL752) ( pir⏝epe⏝mat ) • Improve balance and reduce falls in Parkinson’s (PD-Falls) • Ongoing randomized, placebo-controlled Phase IIb clinical trial • Wholly-owned unencumbered asset
Slide 19: Why preventing falls in Parkinson's?
Pirepemat Why preventing falls in Parkinson’s? Reducing falls is the greatest medical need and one of the worst aspects of Parkinson’s. • Prospective studies report that 70% of people with Parkinson’s have at least one fall in a year and about 45% fall recurrently. • Median survival in patients that
Slide 20: Pirepemat in development improve balance and reduce falls in Parkinson's
Pirepemat Pirepemat in development improve balance and reduce falls in Parkinson’s PD-Falls patient population – A large unmet need EU5 (DE, ES, FR, IT, • 45% of all people with Parkinson’s fall UK) recurrently US 565,000 JP • Impaired balance and a fear of falling 470,000 275,000 significantly impa
Slide 21: A first-in-class treatment for impaired balance and reduction of falls
Pirepemat A first-in-class treatment for impaired balance and reduction of falls • Combines antagonism at 5HT7 and alpha-2 receptors leading to highly Mechanism of Action specific activation of frontal cortex NA and DA • Well tolerated in clinical studies Tolerability • Dose range defined • Pirepema
Slide 22: Growing body of clinical evidence supporting potential as treatment of falls in Parkinson's
Pirepemat Growing body of clinical evidence supporting potential as treatment of falls in Parkinson’s Clinical studies of pirepemat Phase IIa Phase I: SAD Phase I: tablet in PD with mild Phase IIb Pivotal studies PD-Falls +MAD formulation cognitive PD-Falls impairment • Well tolerated • Well tolerat
Slide 23: Clinical Phase IIb: Improve balance and reduction of falls
Pirepemat Clinical Phase IIb: Improve balance and reduction of falls “A Phase IIb to evaluate the effects of pirepemat on falls frequency as compared to placebo.” Secondary & other objectives • To evaluate the effects of pirepemat on cognitive functions assessed with Montreal Cognitive Assessment (M
Slide 24: Ongoing Phase IIb study evaluating efficacy of pirepemat on falls frequency
Pirepemat Ongoing Phase IIb study evaluating efficacy of pirepemat on falls frequency in Parkinson’s patients Inclusion criteria • Parkinson's patients (55-85 yrs) with mild cognitive impairment 6 weeks Dose Dose 33-37 days • Recurrent falls during the past 3 escalation 12-week treatment period scre
Slide 25: Preclinical projects
Preclinical projects IRL757 Clinical candidate Treat apathy IRL942 Clinical candidate Improve cognitive function and brain health IRL1117 Clinical candidate Once-daily oral treatment of Parkinson’s without troublesome complications
Slide 26: Ongoing preclinical development programs on track
Preclinical Ongoing preclinical development programs on track IRL757 IRL942 IRL1117 Once-daily treatment of Treat apathy in neurology Restore cognitive function Parkinson’s Improvement of cognitive Once-daily treatment of Treatment for apathy Parkinson’s (tremor, rigidity, function bradykinesia) wit
Slide 27: IRL757 is aimed at the huge untreated problem with apathy
Preclinical & IRL757 is aimed at the huge untreated research projects problem with apathy Apathy Loss of initiative, interest and emotional Huge unmet medical need expression/ responsiveness, often found in • Over 10 million US and EU citizens may be affected by people with dementia. apathy • Apathy
Slide 28: IRL942 to improve cognitive function in PD and other neurological indications
Preclinical & IRL942 to improve cognitive function in research projects PD and other neurological indications Cognition Unmet need among a large population Cognition encompasses all • 12 % of adults aged 65 years or more experience cognitive aspects of intellectual decline (CDC) functions and proces
Slide 29: IRL1117 – First orally active, full efficacy, long-acting Parkinson's treatment
Preclinical IRL1117 – First orally active, full efficacy, long-acting Parkinson’s treatment • Current treatment of Parkinson’s is based on levodopa IRL1117 • Limitations of levodopa Current standard-of-care (L-DOPA) objective Therapeutic response • Short duration of action warrants multiple daily Ex
Slide 30: Finance report Q1 2023
Finance report Q1 2023 • Highlights and summary • Analyst coverage
Slide 31: Financial highlights of Q1 2023
Financial report Financial highlights of Q1 2023 • Increased focus on cost control • Investing in the Phase Iib with pirepemat according to plan • Maintaining investment in preclinical development, advancing IRL757 and IRL942 and IRL1117 towards clinical Phase I, leading to higher cost for “external
Slide 32: Analyst coverage
Financial report Analyst coverage • Fredrik Thor and Kevin Sule +46 (0) 545 013 30 info@redeye.se • Dr Gonzalo Artiach Castañón +46 (0)8 566 286 00 • Soo Romanoff and Dr Harry Shrives +44 (0)20 3077 5700 healthcare@edisongroup.com 32
Slide 33: Development portfolio transforming treatment of people living with Parkinson's
Portfolio Development portfolio transforming treatment of people living with Parkinson’s Discovery Preclinical Phase I Phase IIa Phase IIb Phase III Next major event Parkinson’s disease levodopa- Mesdopetam Phase IIb induced dyskinesia (PD-LIDs) Decision on next (IRL790)* D3 antagonist steps in clin
Slide 34: Anticipated key development milestones
Outlook Anticipated key development milestones the next 18 months Q1 ‘23 Q2 ‘23 H2 ’23 H1 ‘24 o IRL1117 CD nomination o Mesdopetam additional o IRL757 Phase I ready o Pirepemat Phase IIb top-line Key milestones o Mesdopetam Phase IIb top- Phase IIb study results to be o Pirepemat Phase IIb results l
Slide 35: IRLAB – at a glance
IRLAB – at a glance Organization Pioneering Validated proof- Broad & Solid Focused strategy positioned for biology & ISP of-concept portfolio success Deep profound Discover and From discovery Five unique drug Experienced understanding of develop through Phase II candidates each international Parkins
Slide 36: Contact:
Contact: Gunnar Olsson, CEO, gunnar.olsson@irlab.se Nicholas Waters, EVP and Head of R&D, nicholas.waters@irlab.se Viktor Siewertz, CFO, viktor.siewertz@irlab.se IRLAB discovers and develops novel drugs for the treatment of Parkinson’s disease and other disorders of the brain. The company’s most adv