Irlab Therapeutics Ab Class A · OMXSTO:IRLAB_A
Irlab Therapeutics Ab Class A — Q2 2022 Earnings Presentation
37 slides from Irlab Therapeutics Ab Class A's earnings presentation, Aug 24, 2022
Slide 1: Transforming life for people living with Parkinson's
IRLAB Transforming life for people living with Parkinson’s Q2 presentation - Aug 24, 2022 Richard Godfrey, 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: Strengthening the leadership of IRLAB
Strengthening the leadership of IRLAB "Lam grateful for the warm welcome | have received. Having spent the summer taking a deep dive into our science and pipeline, |am convinced that we have a robust pipeline that will both transform the quality of life for patients living with Parkinson's and deliv
Slide 4: IRLAB is poised for success
IRLAB is poised for success * After 8 years of research and development, 4 drugs candidates are poised for significant high value inflection points in the near future * Leadership team strengthened with a new CEO to allow executive focus on commercial priorities and R&D program delivery * Discovery
Slide 5: IRLAB develops new Parkinson's drugs with blockbuster potential
IRLAB develops new Parkinson’s drugs with blockbuster potential 1. Proprietary drug discovery platform — ISP * Rapid, efficient and successful in-house small molecule drug discovery process * Systems biology: medicinal chemistry + phenotypic in-vivo screening + machine learning 2. Patient focused, b
Slide 6: IRLAB has a highly experienced management and near-term inflection points
IRLAB has a highly experienced management and near-term inflection points 4. Experienced organization * Founders are successful serial biotech entrepreneurs, with >30 years research experience in PD * Founded on pioneering PD research by Prof. Arvid Carlsson, for which he was awarded the Nobel Prize
Slide 7: Parkinson's continues to be common and debilitating disease
Parkinson’s continues to be common and debilitating disease 9 million patients, the second most common neurodegenerative disease after Alzheimer’s * Itis a chronic and progressive disease with no cure * Caused by loss of brain cells that produce dopamine * Dopamine has central role in how the brain
Slide 8: Mesdopetam
Mesdopetam Mesdopetam is designed to reduce levodopa-induced dyskinesia PD-LIDs patients globally’ > ot 110 000 : 470 000 * Ina typical day, people living with Parkinson’s wake up with very challenging stiffness and slowness of movement - they are OFF * Levodopa alleviates the OFF and is necessary t
Slide 9: Pirepemat
Pirepemat Pirepemat is designed to improve balance and reduce falls in Parkinson's PD-Falls patient population - Alarge unmet need EU5 * 45% of all people with Parkinson’s fall ee ve ‘e recurrentl Y US 565,000 J * Impaired balance and a fear of falling P significantly impair the daily lives of CN f2
Slide 10: Parkinson's patient journey and IRLAB's solutions
Parkinson’s and Patient journey, living with Parkinson’s IRLAB's solutions IRLAB PD portfolio transforms the treatment algorithm Objective Early-stage Advanced/late-stage” p (Balance/falls Speech/swallowing . | Freezingof —_ difficulties Pirepemat (Phase IIb) gait - (~ Cognitive fecicere Confusion I
Slide 11: Financials, R&D update, Outlook
g ¥ Financials 4 * Financial highlights Wi + Analyst coverage iS = Q&A session Q2 update », & R&D update 3) . * Mesdoeptam Si 4 « Pirepemat . |: Preclinical (IRL942, IRL757, POO3 Outlook * Pipeline * Newsflow and outlook IRLAB "
Slide 12: Q2 update: Operational highlights
Q2 update Operational highlights in the second quarter (including post-period end) * The management team strengthened by appointing Richard Godfrey as new CEO and Nicholas Waters as Executive Vice President and Head of Research & Development, effective July 1, 2022. * Know-how acquired to support a
Slide 13: Q2 update: Financial highlights
Q2 update Financial highlights in the second quarter * Net sales recorded in Q2 SEK 23.4m (SEKOm) * Total operating expenses during the quarter SEK 50.6 (SEK 26.5m) * The operational loss for the quarter SEK 27.0m (SEK 26.5m) * Cash flow from operations SEK-44.0m (SEK-23.4m) * Cash and cash equivale
Slide 14: Mesdopetam
Innovation for patient care Ta IPSEN Mesdopetam tru70) (mes_dop_e tam) ¢ lpsen acquired the exclusive global license to develop and commercialize mesdopetam * Mesdopetam counteracts levodopa-induced dyskinesia (PD-LIDs) by inhibiting dopamine D3 receptors ¢ Treatment and prevention of psychosis in P
Slide 15: Mechanism: Dopamine D3 receptor antagonist
Mechanism: Dopamine D3 receptor antagonist Dopamine receptors D1 and D2 in the striatum of the brain control movement In PD, the neurons that release dopamine are lost and the control of movement is weakened Levodopa is an effective drug to replace the loss of dopamine in Parkinson’s and restores mo
Slide 16: Mesdopetam's efficacy in Phase Ib & IIa studies highly clinically relevant
Mesdopetam Mesdopetam’s efficacy in Phase lb & lla studies highly clinically relevant * The patient reported outcomes (PROs) in the studies suggest that adding mesdopetam to their otherwise stable anti-parkinsonian treatment can improve the quality of daily motor function by reducing troublesome dys
Slide 17: Efficacy and tolerability is studied in the ongoing Phase IIb study
Efficacy and tolerability is studied in the ongoing Phase Ilb study Study design * 154 patients at 46 sites in in Europe, Israel and the US * Four treatment arms * Three different doses (2.5, 5 and 7.5mg b.i.d) * and placebo group * Three months treatment * The study is powered to detect ~3 hours in
Slide 18: One of the largest licensing agreements in Swedish biotech
Mesdopetam One of the largest licensing agreements in Swedish biotech IRLAB is eligible to receive up to $363 million plus royalties of g IPGSENI worldwide sales: ; . . . _ a Innovation for patient care * lpsen is responsible for all remaining clinical development and 5 aR a Type Global, mid-sized w
Slide 19: Pirepemat
Te IRLAB Pire pe Mat «rv7s2 ( 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 7 IRLAB it
Slide 20: Mechanism of action: pirepemat
Pirepemat Mechanism of action: pirepemat * In Parkinson’s, cognitive impairment, postural instability, and falls (balance impairment) occurs due to loss of NE & DA transmission in the cerebral cortex of the brain * Levodopa does not restore neuronal function in the cerebral cortex * Pirepemat design
Slide 21: Clinical development path for pirepemat
Pirepemat Clinical development path for pirepemat: Improvement of balance and falls BB completed Ongoing Planned Phase Ila Phase |: SAD+MAD PD-cortical Phase Il Pivotal studies : . PD-Falls impairment -—__¢}_____o—____++-e—____e——_— o Evaluate the effects on Parkinson's motor function v Well tolerat
Slide 22: Phase IIa clinical proof-of-concept
Pirepemat Phase lla clinical proof-of-concept® Pirepemat improves the executive functions associated with Parkinson’s Pirepemat affects the Parkinson’s symptoms errintamenottrestedioyllevsdens not treated by levodopa Postural Tremor Riaity —Brodykinesia dysfunction 35% improvement in balance? 53% re
Slide 23: Phase IIb study evaluating efficacy of pirepemat on falls frequency
Pirepemat Phase IIb study evaluating efficacy of pirepemat on falls frequency in Parkinson’s patients . spe Data expected YE 2023 Inclusion criteria * Parkinson's patients (55-85 yrs) with 23 12-week treatment period mild cognitive impairment follow-up * Recurrent falls during the past 3 months and
Slide 24: Preclinical development: IRL942, IRL757 and the P003 project
Te IRLAB Preclinical development: IRL942, IRL757 and the POO3 project IRL942 Restore cognitive function IRL757_ +‘ Treat apathy in neurology (Target populations: Parkinson’s, dementias, schizophrenia, depression) POO3 = Once-daily treatment of Parkinson’s Without the troublesome complications 7 IRLA
Slide 25: IRL942 to improve cognitive function in neurological indications
IRL942 to improve cognitive function in neurological indications IRL942 opportunity * 12 % of adults aged 65 years or more experience cognitive decline (CDC) Problem * Disruption of frontal neurocircuits are implicated in the pathogenesis of cognitive decline IRLAB’s solution * IRL942 show a unique
Slide 26: IRL757 to treat apathy in neurological indications
° ° IRL757 IRL757 - to treat apathy in neurological indications IRL757 opportunity Apathy * Over 10 million US and EU citizens each may be affected by apathy Loss of initiative, interest and * Apathy occurs in 20-70% in people with Parkinson's and in 20-90% emotional expression/ ; of people with Alz
Slide 27: P003 is the next generation Parkinson's treatment
POO3 POO3 is the next generation Parkinson’s treatment Objective: once-daily, orally available, treatment of core motor symptoms of Parkinson’s without the complications Current standard-of-care (levodopa) P003 objective © Excessive * Total market (16 largest regions): 8.3 million z response people
Slide 28: Pipeline generated with our unique ISP proprietary drug discovery platform
Pipeline generated with our unique ISP 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 29: Finance report Q2 2022
naa TRLAB IL Finance report Q2 2022 * Highlights and summary ° Analyst coverage
Slide 30: Financial highlights of Q2 2022
Financial highlights of Q2 2022 ees Geopolitical events and global economics have increased our focus on cost control * Investing in two clinical Phase IIb programs according to plan * Investing in preclinical development, advancing IRL757 and IRL942 towards clinical Phase | * Strong cash position S
Slide 31: Financial summary of Q2 2022
Financial summary of Q2 2022 Highlights Financial report * Strong cash position: SEK Net sales 23,410 0 32,452 0 207,782 323m Operating profits/loss -27,015 -26,520 -56,103 -46,487 52,576 Profit/loss for the period -27,115 -26,520 -56,285 -46,670 51,781 * Cash flow increasing due to Earnings per sha
Slide 32: Analyst coverage
Analyst coverage REDEYE * Fredrik Thor and Kevin Sule NORDIC GROWTH AB G * Dr Adam Karlsson and Dr Gonzalo Artiach SUNDAL COLLIER is EDISON BRILLIANT KNOWLEDGE * Soo Romanoff and Dr Harry Shrives Financial report +46 (0) 545 013 30 info@redeye.se +46 (0)8 566 286 00 +44 (0)20 3077 5700 healthcare@ed
Slide 33: Pipeline transforming treatment of people living with Parkinson's
Pipeline transforming treatment of people living with Parkinson’s PRE DISCOVERY Gy iyicay PHASE! PHASElla PHASElib PHASE II MESDOPETAM (IRL790) D3 antagonist PIREPEMAT (IRI PFC Enhancer** PIREPEMAT (IRL7521 PFC Enhancer** Mesdopetam * $1Psen PARKINSON’S ~ LEVODOPA-INDUCED DYSKINESIAS (LIDS) PARKINSO
Slide 34: Anticipated newsflow the next months
Anticipated newsflow the next 18 months Outlook Q3 ‘22 Q4 ‘22 H1 2023 H2 2023 o Pirepemat Phase Ilb study update o Mesdopetam Phase IIb recruitment closed o Mesdopetam Phase IIb last patient randomized o 8 Sep: Pareto Securities Annual HC Conference, Stockholm o 13 Sep: ABGSC Investor Day, Stockholm
Slide 35: Outlook
Outlook Foundation for transformative treatments 2020 - 2023 Mesdopetam Successful completion of Phase IIb study Pirepemat Successful completion of Phase IIb study Pipeline Initiate Phase | studies with IRL942 and IRL757 Initiate preclinical development of CD from PO03 Continued ISP development Busi
Slide 36: Investment case
Investment ener Pioneering Validated proof- biology & ISP Focused strategy Four shots on goal Deep profound understanding of Parkinson's based on research by Nobel laurate Prof. Arvid Carlsson Treating PD patients throughout disease journey, has blockbuster potential as a pharma business 5S IPSEN In
Slide 37: IRLAB
IRLAB Contact: Richard Godfrey, CEO, richard.godfrey@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’