Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q2 2023 Earnings Presentation
43 slides from Irlab Therapeutics Ab Class A's earnings presentation, August 2023
Slide 1: Transforming life for people living with Parkinson's
ATT UPPDATERS med ny bild David o henke? Transforming life for people living with Parkinson’s Q2 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
Business Today’s agenda update 1 News in the period 4 Concluding remarks 2 R&D update 3 Financials 5 Q&A session 3
Slide 4: Operational highlights in the second quarter
Q2 update Operational highlights in the second quarter • Mesdopetam • In May a discussion was initiated with Ipsen to outline the best way forward for mesdopetam towards registration and make it available to people living with Parkinson’s disease • IRL757 and IRL942 • In May, IRLAB and the McQuade C
Slide 5: Operational highlights in the second quarter
Q2 update Operational highlights in the second quarter • ISP • 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 • AGM • On June 20, the company’s annual general meeting was he
Slide 6: Operational events after end of period
Q2 update Operational events after end of period • Pirepemat • In mid-July the independent safety and data monitoring board, DSMB, gave a unanimous recommendation to continue the ongoing Phase IIb study with pirepemat in accordance with the approved study protocol following the first pre-planned dat
Slide 7: Operational events after end of period
Q2 update Operational events after end of period • Mesdopetam • On August 21, the ownership and rights to the Phase III-ready mesdopetam project was secured to IRLAB. IRLAB now controls the continued clinical development and commercialization • On August 22, IRLAB gave an update on the mesdopetam pr
Slide 8: Financial highlights in the second quarter
Q2 update Financial highlights in the second quarter • Net revenue SEK 6.9m (SEK 23.4m) • Total operating expenses SEK 51.7m (SEK 50.6m) • Operating result SEK –44.9m (SEK –27.0m) • Cash flow from operating activities: SEK –52.8m (SEK -44.0m) • Cash and cash equivalents at the end of the period: SEK
Slide 9: IRLAB – a world-leading portfolio to improve Parkinson's treatments
IRLAB – a world-leading portfolio to improve Parkinson’s treatments Validated business Organization Pioneering Broad & Solid Focused strategy model based on clinical positioned for biology & ISP proof-of-concept portfolio success Deep profound Discover and From discovery Five unique drug Experienced
Slide 10: 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 11: The most bothersome symptoms according to people with Parkinson's
The most bothersome symptoms according to people with Parkinson’s What bothers people with Parkinson’s disease the most ? Self-reported, n=25 000 (the Fox Insight project, Michael J. Fox Foundation) Most frequent bothersome symptoms • Balance/instability • Hallmark symptoms • Tremor • Rigidity • bra
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 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 13: Pipeline generated with our unique proprietary drug discovery platform - ISP
Pipeline generated with our unique proprietary drug discovery platform - ISP ISP: a new level for drug discovery • Advanced systems biology technology to discover new candidate drugs (CD) • First-in-class drugs • Generates strong IP • Identifies use area with largest potential for the CD • Gives hig
Slide 14: 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- Phase III Mesdopetam induced dyskinesia (PD-LIDs) ready • End-of-Phase 2 (IRL790) D3 antagonist meeting
Slide 15: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive Hallmark symptoms: impairment Apathy Hallucinations • Tremors Balance and falls Confusion Freezing when Motor • Bradykinesia Depression walking symptoms Slow Speec
Slide 16: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis Psychosis symptoms Cognitive impairment Apathy Hallucinations Balance and falls Confusion Freezing when Motor Depression walking symptoms Slow Speech movements Dyskinesia impairment
Slide 17: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive Cognitive Pirepemat impairment impairment Apathy Hallucinations Balance and falls Confusion Freezing when Motor Depression walking symptoms Slow Speech Speech move
Slide 18: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive impairment Apathy Hallucinations Balance and falls Confusion Freezing when Motor Depression walking symptoms Slow Speech IRL757 movements impairment Dyskinesia Sti
Slide 19: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive Cognitive impairment impairment Apathy Hallucinations Balance and falls IRL942 Confusion Freezing when Motor Depression walking symptoms Slow Speech movements impa
Slide 20: Parkinson's disease development
Parkinson’s disease development Initial symptoms before diagnosis Parkinson’s disease diagnosis Psychiatric Psychosis symptoms Cognitive impairment Apathy Hallucinations Balance and falls Confusion Freezing when Motor Depression walking symptoms Slow Slow Speech movements movements impairment Dyskin
Slide 21: World-leading portfolio to improve the treatment of Parkinson's
World-leading portfolio to improve the treatment of Parkinson’s Initial symptoms before diagnosis Parkinson’s diagnosis IRLAB’s portfolio with first-in- class drug candidates to treat people with Parkinson’s during all stages of disease: Psychiatric Psychosis symptoms Cognitive Pirepemat impairment
Slide 22: 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)
Slide 23: Mesdopetam - growing body of clinical evidence supporting a novel treatment of dyskinesia in PD
Mesdopetam Mesdopetam - growing body of clinical evidence supporting a novel treatment of dyskinesia in PD Clinical studies of mesdopetam Phase IIb Pivotal studies PD-LIDs Phase I: SAD Phase Ib Phase IIa PD-LIDs +MAD PD-LIDs* PD-LIDs Phase II Phase I PD-Psychosis PK* • Well tolerated • Well tolerate
Slide 24: Mesdopetam - Phase IIb study conclusions
Results Mesdopetam - Phase IIb study conclusions • Consistent dose-response and clinically meaningful “Good ON” UDysRS OFF-time anti-dyskinetic efficacy • Improvement in UDysRS • Improvement in “good ON”-time • Consistent dose-response pattern in reduction in OFF-time, i.e., anti-parkinsonian effica
Slide 25: Mesdopetam - Phase I studies were successfully completed and showed favorable results
Phase III Mesdopetam - Phase I studies were successfully preparation completed and showed favorable results 1. Pharmacokinetics (PK) in Asians and Non-Asians • PK profile for mesdopetam similar in the different populations 2. Drug-Drug Interaction PK study • Low risk of drug-drug interactions • Sugg
Slide 26: Mesdopetam - Next steps
Mesdopetam - Next steps Prepare for an end-of-Phase 2 meeting with the FDA Prepare briefing book in collaboration with regulatory and clinical advisors, as well as support from Ipsen, to define Phase III program Capitalize on options for financing of Phase III 26
Slide 27: 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
Slide 28: Pirepemat - in development for improvement of balance and reduce falls in Parkinson's
Pirepemat Pirepemat - in development for improvement of balance and reduce falls in Parkinson’s • 45 % of individuals with Parkinson fall recurrently • Cost of a fall injury approx. 30 000 USD in patients > 65 years PD-Fall patient population • There is no available treatment despite the large EU5 u
Slide 29: Pirepemat - A first-in-class treatment for impaired balance and reduction of falls
Pirepemat 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 define
Slide 30: Pirepemat: Growing body of clinical evidence supporting potential as treatment of falls in Parkinson's
Pirepemat 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 • W
Slide 31: 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 • Recurrent falls during the past 3 6 weeks 33-37 days Dose Dose months and at least 2 falls during escal
Slide 32: Preclinical projects
Preclinical projects IRL757 drug candidate IRL942 drug candidate IRL1117 drug candidate
Slide 33: Preclinical projects
Preclinical Preclinical projects 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) without Loss of initiative, inte
Slide 34: 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 35: 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 36: IRL1117: Next generation treatment of Parkinson's
IRL1117: Next generation treatment of Parkinson Aim: long-acting treament for cardinal symptoms in Parkinson disease • Mono-therapy as well as add on to levo-dopa • Potential – effective treatment without driving complications seen with available treatments (i.e. levodopa) • Market (16 largest regio
Slide 37: Finance report Q2 2023
Finance report Q2 2023 • Highlights and summary • Analyst coverage
Slide 38: Financial highlights of Q2 2023
Financial report Financial highlights of Q2 2023 • Maintained 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 • Cash position SEK 156 million Gray
Slide 39: 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 39
Slide 40: 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- Phase III Mesdopetam induced dyskinesia (PD-LIDs) ready • End-of-Phase 2 (IRL790) D3 antagonist meeting
Slide 41: Anticipated key development milestones the next 12 months
Anticipated key development milestones the next 12 months Q3 2023 Q4 2023 H1 2024 • Mid-July: 1st DSMB review and • 2nd DSMB review of the Phase • Pirepemat Fas IIb top-line recommendation to continue II study of pirepemat resultat Phase IIb study with pirepemat • Pirepemat patient recruitment • IRL
Slide 42: IRLAB – a world-leading portfolio to improve Parkinson's treatments
IRLAB – a world-leading portfolio to improve Parkinson’s treatments Validated business Organization Pioneering Broad & Solid Focused strategy model based on clinical positioned for biology & ISP proof-of-concept portfolio success Deep profound Discover and From discovery Five unique drug Experienced
Slide 43: 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 is discovering and developing a portfolio of transformative therapies targeting all stages of Parkinson’s disease. The company has i