Herantis Pharma Plc · OMXHEX:HRTIS

Herantis Pharma — Technical Presentation (October 2023)

16 slides from Herantis Pharma's technical presentation, Oct 25, 2023

  1. Slide 1: Phase 1a Topline Results Webinar

    Phase 1a Topline Results Webinar October 25, 2023 www.herantis.com © 2014-2023 HERANTIS PHARMA Plc. All rights reserved.

  2. Slide 2: Forward-looking Statement

    Forward-looking Statement This company presentation includes forward-looking statements which are not historical facts but statements regarding future expectations instead. These forward-looking statements include without limitation, those regarding Herantis’ future financial position and results of

  3. Slide 3: Herantis – At a Glance

    Herantis – At a Glance Herantis Pharma plc was founded in Helsinki, Finland in 2008; Listed at Nasdaq First North Helsinki Developing disease-modifying treatment to address the unmet clinical need in Parkinson’s disease and other neurodegenerative diseases Lead asset HER-096 is a small engineered pe

  4. Slide 4: HER-096 is a Perfect Drug Candidate for Parkinson's Disease

    HER-096 is a Perfect Drug Candidate for Parkinson’s Disease HER-096 HER-096 • Synthetic peptidomimetic molecule OPTIMIZATION • Designed based on the active site of CDNF protein ACTIVE • Unique and broad Mechanism of Action: Modulation of Unfolded Protein SITE Response (UPR) pathway to reduce cell st

  5. Slide 5: Brief Summary of the Positive Topline Phase 1a Data

    Brief Summary of the Positive Topline Phase 1a Data • HER-096 Phase 1a clinical trial met primary and secondary endpoints • Subcutaneous single dose injection of HER-096 had overall good safety and tolerability profile • Pharmacokinetic data showed ▫ Quick absorption of subcutaneously injected HER-0

  6. Slide 6: Phases of Drug Development Before Market Authorization

    Phases of Drug Development Before Market Authorization NON-CLINICAL DEVELOPMENT CLINICAL DEVELOPMENT Discovery Preclinical Phase 1 Phase 2 Phase 3 • Target molecule • Lead optimization • Safety in healthy • Safety in patients • Safety and efficacy in validation • Preclinical proof-of- volunteers bro

  7. Slide 7: HER-096 Phase 1a First-in-Human Trial Design and Objectives

    HER-096 Phase 1a First-in-Human Trial Design and Objectives Part 1: Part 2: Study design: Male, age 20-45 years Male & female, age >50 years • Double-blind, placebo-controlled clinical trial • Subcutaneously administered single ascending dose of HER-096 to healthy subjects Single dose, 300 mg 2 plac

  8. Slide 8: Summary of Adverse Events

    Summary of Adverse Events Part 1: Dose escalation cohort 10 mg (n=6) 30 mg (n=6) 60 mg (n=6) 120 mg (n=6) 200 mg (n=6) 300 mg (n=6) Placebo (n=12) AEs (number / subjects) 8 / 4 (67%) 11 / 6 (100%) 10 / 4 (67%) 14 / 5 (83%) 17 / 6 (100%) 25 / 6 (100%) 11 / 7 (58%) TEAEs (number / subjects) 3 / 3 (50%

  9. Slide 9: Safety Data Allows Further Clinical Development

    Safety Data Allows Further Clinical Development • Overall good safety and tolerability profile in young (20-45 y) healthy males, and older (50-64 y) and elderly (65-75 y) healthy females and males. • No Serious Adverse Events (SAE). • One significant AE was reported, where a subject experienced a va

  10. Slide 10: Pharmacokinetic Data Shows Expected Absorption and Elimination Profile in Plasma

    Part 1 Pharmacokinetic Data Shows Expected Absorption and Elimination Profile in Plasma HER-096 Plasma PK byindose plasma groups 12000 10 mg 30 mg 60 mg 120 mg 200 mg 300 mg HER-096 in plasma (ng/ml) 10000 Cmax (ng/ml) 363 906 2235 3468 5406 9663 300 mg Tmax (h) 2.01 1.34 0.71 1.14 1.06 0.81 8000 20

  11. Slide 11: Plasma Data Shows Similar Pharmacokinetics in Elderly Subjects

    Part 2 Plasma Data Shows Similar Pharmacokinetics in Elderly Subjects Plasma PK by gender HER-096 in plasma Males HER-096 in plasma (ng/ml) 8000 Males Females Females Cmax (ng/ml) 5573 7333 6000 Tmax (h) 0.84 0.91 T1/2 (h) 2.66 2.39 4000 AUClast (h*ng/ml) 31354 42202 AUCinf (h*ng/ml) 31455 42279 200

  12. Slide 12: Pharmacokinetic Data Shows Efficient BBB Penetration in Humans

    Part 2 Pharmacokinetic Data Shows Efficient BBB Penetration in Humans CSF HER-096 in cerebrospinal fluid (CSF) 150 HER-096 in CSF (ng/ml) 125 100 Male, 50-64 y Female, 50-64 y CSF 75 Pr ed Mean concentration (ng/ml) 72.6 (range: 15.2 – 96.9) ict ed Male, >65 y 50 Female, >65 y 25 0 LLOQ = 0.1 ng/ml

  13. Slide 13: Phase 1a Trial: Conclusions

    Phase 1a Trial: Conclusions • Primary endpoint was met ▫ Single subcutaneous dose of HER-096 (from 10 to 300 mg) were found to be safe and well-tolerated in healthy subjects • Secondary endpoints were met ▫ Single ascending doses of HER-096 in healthy subjects showed an expected plasma pharmacokinet

  14. Slide 14: We Have a Strong Data Package on HER-096

    We Have a Strong Data Package on HER-096 • We believe that we have a strong data package on HER-096 to continue clinical development and to advance the partnering process ▫ Preclinical evidence of HER-096 therapeutic effects in a Parkinson’s disease model (mouse a-synuclein model) ▫ The first-in-man

  15. Slide 15: Summary

    Summary What we want to achieve To develop a treatment to slow or stop the progression of with HER-096? Parkinson’s disease with symptomatic relief • Therapeutic concentration of HER-096 in the central nervous Evidence of subcutaneous system in humans HER-096 • Good safety and tolerability profile i

  16. Slide 16: Thank you!

    Thank you! Contact details: CEO Antti Vuolanto, [email protected] CFO Tone Kvåle, [email protected] CSO Henri Huttunen, [email protected] www.herantis.com © 2014-2023 HERANTIS PHARMA Plc. All rights reserved. 16

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