Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q3 2023 Earnings Presentation
35 slides from Irlab Therapeutics Ab Class A's earnings presentation, October 2023
Slide 1: World-leader in drug development in Parkinson's
World-leader in drug development in Parkinson’s: Reducing the burden and transforming lives IRLAB, Q3 2023
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 Gunnar Olsson, CEO 4 Concluding words 2 R&D update Nicholas Waters, EVP Head of R&D 3 Financials 5 Q&A session Viktor Siewertz, CFO 3
Slide 4: Operational highlights in the third quarter: Pirepemat
Q3 update Operational highlights in the third quarter Pirepemat • In July, the Data Safety Monitoring Board (DSMB) unanimously recommended continuing the ongoing Phase IIb study of pirepemat per the approved study protocol following a planned review of the first 25 patients having completed the stud
Slide 5: Operational highlights in the third quarter: Mesdopetam
Q3 update Operational highlights in the third quarter Mesdopetam • The full ownership of the now Phase III-ready mesdopetam project was secured by IRLAB in August. Simultaneously, IRLAB confirmed its intention to continue with Phase III development of mesdopetam. • An in-depth analysis of the Phase
Slide 6: Operational highlights: Business development and financing
Q3 update Operational highlights in the third quarter Business development and financing • Business Development – increased activities in the evaluation of potential collaboration partners and licensees • Investors – continued financing activities with participation in conferences as well as discuss
Slide 7: Operational events after end of period
Q3 update Operational events after end of period Mesdopetam • In October, a collaboration commenced with the US regulatory advisors Clintrex, who leads IRLAB’s US regulatory strategy, and ProPharma Group, who acts as IRLAB’s regulatory agent in the US. Together with our advisors IRLAB is now prepari
Slide 8: Financial summary of third quarter
Financial summary of third quarter All amounts in SEK Q3 2023 Q3 2022 Net sales - 16.5m Operating profit - 40.7m - 23.9m Earnings per share before and after dilution, SEK - 0.74 -0.46 Cash and cash equivalents 118.8m 291.7 Cash flow from operating activities - 36.7m 27.9 Average number of employees
Slide 9: R&D update
rm | TIRLAB It R&D update
Slide 10: What bothers people with Parkinson's disease the most?
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 11: Parkinson's disease progresses over time – symptoms and complications expand
Parkinson’s disease progresses over time – symptoms and complications expand 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 • Bradyk
Slide 12: World-leading portfolio to improve treatment of Parkinson's
Parkinson’s and Parkinson’s disease World-leading progresses portfolio overthe to improve time – IRLAB’s portfolio symptoms of treatment and complications expand Parkinson’s Initial symptoms before diagnosis Parkinson’s disease diagnosis IRLAB’s portfolio with first-in- class drug candidates to trea
Slide 13: Mesdopetam (IRL790)
Mesdopetam (IRL790) ( mes⏝dop⏝e⏝tam ) • Mesdopetam counteracts levodopa-induced dyskinesias (PD-LIDs) by a novel mechanism inhibiting dopamine D3 receptors
Slide 14: Mesdopetam (IRL790)
Mesdopetam (IRL790) Patent-based First in class- a novel Inhibiting dopamine exclusivity into the mechanism D3 receptors 2040s Lead indication – levodopa-induced dyskinesias (PD-LIDs) 14
Slide 15: Growing body of clinical evidence supporting a novel treatment of dyskinesia
Mesdopetam Growing body of clinical evidence supporting a novel treatment of dyskinesia in Parkinson’s Clinical studies of mesdopetam Completed Ongoing Planned Phase IIb PD-LIDs Phase Ib Phase IIa Phase I DDI Phase I: SAD Pivotal study program Phase I HMB +MAD PD-LIDs* PD-LIDs PD-LIDs Phase I specia
Slide 16: Mesdopetam - Phase IIb study conclusions
Mesdopetam Mesdopetam - Phase IIb study conclusions FAS population PS population ”Good ON” UDysRS OFF-time ”Good ON” UDysRS OFF-time -12.0 • Consistent dose-response and clinically meaningful anti- • No untoward effects on normal motor functions or PD dyskinetic efficacy symptoms, i.e., no increase
Slide 17: Pirepemat (IRL752)
Pirepemat (IRL752) ( pir⏝epe⏝mat ) • Pirepemat is designed to improve balance and reduce falls in Parkinson’s (PD-Falls) • Ongoing randomized, placebo-controlled Phase IIb clinical trial
Slide 18: Pirepemat (IRL752)
Pirepemat (IRL752) Patent-based First in class- a novel Inhibiting alpha 2 and exclusivity into the mechanism serotonin 7 receptors 2040s Objective – reduce falls in Parkinson’s disease 18
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: Clinical development path for pirepemat
Pirepemat Clinical development path for pirepemat: Improvement of balance and falls Completed Ongoing Planned Phase IIa Phase IIb Phase I: SAD+MAD PD-cortical Pivotal studies PD-Falls impairment* ü Well tolerated ü Well tolerated Evaluates effects on ü Good ü Improves: o Falls frequency pharmaco- ü
Slide 21: Pirepemat - in development to improve balance and reduce falls
Pirepemat Pirepemat - in development to improve balance and reduce falls in Parkinson’s • 45% of individuals with Parkinson’s fall recurrently PD-Fall total patient population • Cost of a fall injury approx. 30 000 USD in patients – 2.6 million1 – > 65 years • There is no available treatment despite
Slide 22: 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 23: Preclinical projects in development
Preclinical Preclinical projects in development projects IRL757 IRL942 IRL1117 Treatment for Improvement of cognitive Once-daily treatment of apathy function Parkinson’s (tremor, rigidity, bradykinesia) without treatment- related complications Loss of initiative, interest, and Memory, perception, at
Slide 24: Finance report Q3 2023
Finance report Q3 2023 • Highlights and summary • Analyst coverage
Slide 25: Financial highlights of Q3 2023
Financial highlights of Q3 2023 • Cash position SEK 119 million • Continued focus on cost control, prioritizing cost that will preserve or increase value in the projects • Investing in the Phase IIb with pirepemat according to plan • Maintaining investment in preclinical development, advancing IRL75
Slide 26: Analyst coverage
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 +44 (0)20 3077 5700 healthcare@edisongroup.com 26
Slide 27: Concluding words
rm | TIRLAB It Concluding words
Slide 28: Our strategy
Our strategy • Addressing all stages of Parkinson’s disease and other CNS disorders • Discovering novel candidate drugs (CDs) with our ISP platform • True innovation • Higher success rate • Strong IP position • Developing CDs from discovery to Proof-of-Concept (PoC) • Seeking partnering after PoC 28
Slide 29: Key developments and growth of the project portfolio during 2023
Key developments and growth of the project portfolio during 2023 • Mesdopetam • Phase IIb read out – Phase III readiness • Secured full ownership and rights to the product • Pirepemat • Phase IIb study ongoing - all clinical sites opened • First pre-specified DSMB evaluation – continue according to
Slide 30: 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 31: Business development efforts
Business development efforts Partnering Awareness of IRLAB Continuous and Near term focus on opportunities being and the development frequent dialogue with mesdopetam evaluated across the pipeline is increasing potential partners and IRL757/IRL942 portfolio 31
Slide 32: Our key priorities are focused on value-creating activities
Our key priorities are focused on value- creating activities Clinical development • End-of-Phase 2 meeting with the FDA to define the Phase III program for mesdopetam • Complete recruitment for the Phase IIb study of pirepemat and present top- line results Preclinical development • Drive the develop
Slide 33: Multiple possibilities for high value creation during the next 18 months
Multiple possibilities for high value creation in the project portfolio during the next 18 months Mesdopetam • End-of-Phase 2 meeting with the FDA • BD activities for Phase III Pirepemat • Top-line results from Phase IIb study in PD-Falls • BD activities for Phase III Preclinical • IRL757 and IRL942
Slide 34: 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 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