Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q4 2022 Earnings Presentation
35 slides from Irlab Therapeutics Ab Class A's earnings presentation, February 2023
Slide 1: Transforming life for people living with Parkinson's
Transforming life for people living with Parkinson’s 2022 Q4 and Year-end summary Gunnar Olsson, CEO Nicholas Waters, EVP and Head of R&D
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 • Opening words • News in the period 4 • Portfolio • Newsflow & events 2 R&D update • Mesdopetam • Pirepemat • Preclinical programs 3 Financials • Financial highlights • Analyst coverage 5 Q&A session 3
Slide 4: Opening words
Opening words • Organizational changes Our 2023 strategic priorities • Management 1. Fully describe the potential of • Board mesdopetam to be an effective treatment for people in Parkinson’s disease. • Way forward 2. Publish and present the comprehensive • Working closely with management team result
Slide 5: Operational highlights in the fourth quarter
Q4 update Operational highlights in the fourth quarter • Solid progress in clinical, preclinical and research projects, according to plan • Phase IIb study of mesdopetam in people with Parkinson’s levodopa-induced dyskinesias (PD-LIDs) • Fully recruited • Database lock year-end 2022 • Top-line resul
Slide 6: Operational highlights after end of period
Q4 update Operational highlights after end of period • 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. • Drug candidate IRL1117 was nominated from the P0
Slide 7: Objectives at different stages of clinical development
Q4 update Objectives at different stages of clinical development Phase I • Pharmacokinetics • Safety and tolerability Phase IIa • Safety and tolerability • Exploration of efficacy signals Phase IIb • Establish dose response and dose selection • Safety and tolerability • Document efficacy in larger p
Slide 8: Operational highlights after end of period
Q4 update Operational highlights after end of period • 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. • Drug candidate IRL1117 was nominated from the P0
Slide 9: Financial highlights in the fourth quarter
Q4 update Financial highlights in the fourth quarter • Net sales recorded: SEK 12.2m (SEK 12.1m) • Total operating expenses: SEK 45.8m (SEK 35.0m) • The operating result: SEK –33.1m (SEK -23.1m) • Cash flow from operations: SEK –37.9m (SEK -28.4m) • Cash and cash equivalents at the end of the period
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 Treating PD One clinical Five unique drug Experienced understanding of patients program already candidates each international Parkinson’
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: 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 disorders Identified treatment priorities IRLAB’s solution 2040 • Impaired balance and falls Pirepemat 12.9 • Cognitive decline Pirepemat, IRL942, IRL757 million
Slide 13: 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 14: 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 15: Mesdopetam (IRL790)
Mesdopetam (IRL790) ( mes⏝dop⏝e⏝tam ) • Mesdopetam counteracts levodopa-induced dyskinesias (PD-LIDs) by inhibiting dopamine D3 receptors • Potential treatment and prevention of psychosis in Parkinson’s (PD-P) • Ipsen licensed the exclusive global rights to develop and commercialize mesdopetam Curre
Slide 16: Mesdopetam's clinical development plan
Mesdopetam Mesdopetam’s clinical development plan Study Treatment Study Design # subjects Primary objectives Status Result Population duration DB placebo Ph I: SAD+ Healthy male SAD+MAD 10 Tolerable, good safety, linear PK, up to 120 mg/day in controlled cross- 16 (SAD) 24 (MAD) PK, safety, tolerabi
Slide 17: Growing body of clinical evidence supporting potential as treatment of dyskinesia in PD
Mesdopetam Growing body of clinical evidence supporting potential as treatment of dyskinesia in PD Clinical development 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
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 can improve balance and reduce falls in Parkinson's
Pirepemat Pirepemat can 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 impair the dail
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: Pirepemat's clinical development plan
Pirepemat Pirepemat’s clinical development plan Treatment Study Study Population Design # subjects Primary objectives Status Result duration DB placebo Single and multiple doses of pirepemat were generally well Ph I: SAD+ Healthy male SAD+MAD 10 controlled 16 (SAD) PK, safety, tolerability Finalized
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 escalation 12-week treatment period follow up screening De-escalation • Recu
Slide 25: Preclinical & Research projects
Preclinical & Research 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) w
Slide 27: Scientific rationale of IRL942 & IRL757
Preclinical Scientific rationale of IRL942 & IRL757 Problem Potential clinical indications: Disruption of frontal neurotransmission is • Parkinson’s disease: dementia, apathy, depression, attention/vigilance implicated in the pathogenesis of cognitive decline • Besides PD dementia, data support pote
Slide 28: 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 29: Finance report Q4 2022
Finance report Q4 2022 • Highlights and summary • Analyst coverage
Slide 30: Financial highlights of Q4 2022
Financial report Financial highlights of Q4 2022 • Sustained focus on cost control • Investing in pirepemat clinical Phase IIb according to plan • Maintaining investment in preclinical development, advancing IRL757 and IRL942 and IRL1117 towards clinical Phase I • Stable cost base (Q2 2022 through Q
Slide 31: 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 31
Slide 32: Portfolio transforming treatment of people living with Parkinson's
Portfolio 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 Ipsen disposition induced dyskinesia (PD-LIDs) (IRL790)* D3 antagonist r.e. further clinical Pa
Slide 33: Milestones
Outlook Anticipated newsflow and events 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 o Mesdopetam Phase IIb top- Phase IIb study results results Milestones o Pirepemat Phase IIb line results compl
Slide 34: 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 Treating PD One clinical Five unique drug Experienced understanding of patients program already candidates each international Parkinson’
Slide 35: 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