Newron Pharmaceuticals S.p.a. · SIX:NWRN

Newron Pharmaceuticals — H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference 2025

25 slides from Newron Pharmaceuticals's conference presentation, Jun 16, 2025

  1. Slide 1: Committed to CNS Drug Development

    COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Stefan Weber, CEO H.C. Wainwright 6th Annual Neuro Perspectives Hybrid Conference June 16 & 17, 2025

  2. Slide 2: Disclaimer

    DISCLAIMER RESTRICTED SCOPE; EXCLUSION OF LIABILITY; CONFIDENTIALITY This document has been prepared by Newron Pharmaceuticals S.p.A. ("Newron") solely for your information. The information contained herein has not been independently verified. No representation or warranty, express or implied, is ma

  3. Slide 3: Company Highlights

    COMPANY HIGHLIGHTS Unique portfolio of innovative Significant value drivers for leading CNS product candidates candidate Evenamide  Xadago® for Parkinson’s disease – Global  First partnered territory: Japan/Asia with approvals validate Newron’s development EA Pharma/Eisai: 12/2024 capabilities fro

  4. Slide 4: Evenamide – Changing the Treatment Paradigm in Schizophrenia

    EVENAMIDE – CHANGING THE TREATMENT PARADIGM IN SCHIZOPHRENIA TPP CLINICAL EVIDENCE  TRS patients: Positive results from 1-year pilot study 014/015 in 161 TRS patients  Large market opportunity  NON-TRS patients: Positive results from pivotal Phase II/III Study 008A  Differentiated MoA and positi

  5. Slide 5: Evenamide partnering agreement with EA Pharma/Eisai

    EVENAMIDE VALIDATION OF EA Pharma / EISAI (top 10 Japan: donepezil/Aricept, lecanemab, Leqembi) to develop evenamide in all indications in Japan and other designated Asian territories - MOA - RESULTS SO FAR Newron to receive - €44m downpayment - INDICATION - €11m of contribution to upcoming Phase II

  6. Slide 6: Schizophrenia - High Medical Need for 20 Million Patients Worldwide

    SCHIZOPHRENIA - HIGH MEDICAL NEED FOR 20 MILLION PATIENTS WORLDWIDE Over 30 antipsychotics available, but all provide short-term and LARGE MARKET insufficient relief of some of the symptoms OPPORTUNITY (anti-psychotics Most patients with schizophrenia demonstrate reduced control of positive market >

  7. Slide 7: Straight to the Heart of the Brain

    STRAIGHT TO THE HEART OF THE BRAIN evenamide HIPPOCAMPUS VTA Dopamine site of deficit Dopamine Receptors Ventral Ventral Striatum Pallidum current antipsychotics 7

  8. Slide 8: Evenamide's Differentiated Mode of Action Demonstrated

    EVENAMIDE’S DIFFERENTIATED MODE OF ACTION DEMONSTRATED Selectively blocks native sodium channels, showing no off-target effect on >130 other CNS receptors, enzymes, transporters, etc. Modulates sustained repetitive firing Selectively blocks VGSCs in a Inhibits without inducing impairment of voltage-

  9. Slide 9: Evenamide: Significant Efficacy in the MAM Model

    EVENAMIDE: SIGNIFICANT EFFICACY IN THE MAM MODEL DOMAIN KEY FINDINGS ON EVENAMIDE Reverses Hippocampal Pyramidal Neuron Hyperactivity Normalizes VTA Dopamine Neuron Population Activity Neuronal Activity Impacts Primarily Lateral VTA Dopamine Effects of evenamide outlast its presence in the brain  I

  10. Slide 10: Evenamide – Differentiation and Commercial Opportunity in Schizophrenia

    EVENAMIDE – DIFFERENTIATION AND COMMERCIAL OPPORTUNITY IN SCHIZOPHRENIA Large market opportunity NO direct competition as Evenamide can be added to all antipsychotics Seeking to change treatment paradigm in schizophrenia First add-on antipsychotic to be First drug for Treatment Resistant Only option

  11. Slide 11: Pilot Study 014/015: Design and Key Characteristics

    PILOT STUDY 014/015: DESIGN AND KEY CHARACTERISTICS Study design: Study Population: A pilot, randomized, open-label, rater-blinded, parallel-group, 6 weeks, multi-center study followed by an extension up to  Treatment-Resistance with documented non-response to at 1 year of treatment with Evenamide

  12. Slide 12: Study 015 – Positive and Negative Syndrome Scale (PANSS)

    STUDY 015 – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) MEAN CHANGE FROM BASELINE (SD) – mITT % Change from baseline 79.5 (5.04) * 70.0 * -9.5 (7.13) 66.5 * -11.9% -12.8 (7.65) 63.9 -16.1% -15.5 (10.18) -19.4% Baseline Week-6 6-Month 1-Year N=156 N=152 N=131 N=127 * p-value vs baseline < 0.001, pai

  13. Slide 13: Study 015 – PANSS Responder Analysis

    STUDY 015 – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) PANSS RESPONDER ANALYSIS (%) – mITT PANSS Total ≥20% Improvement from baseline 84.6 Responder Non Responder 66.0 58.2 41.8 34.0 15.4 Week-6 6-Month 1-Year 13

  14. Slide 14: Study 015 - Patients No Longer Meeting Severity Criteria for TRS

    STUDY 015 - PATIENTS NO LONGER MEETING SEVERITY CRITERIA FOR TRS (mITT; LOCF/OC) SEVERITY CRITERIA VISIT WEEK 6 6-MONTH 1-YEAR STAT LOCF OC LOCF OC LOCF OC N 156 152 156 131 156 120 1. PANSS <70 n (%) 72 (46.1) 72 (47.3) 93 (59.6) 84 (64.1) 99 (63.5) 84 (70.0) 2. Core items* <20 n (%) 60 (38.4) 60 (

  15. Slide 15: Study 014/015 – Proportion of Patients Who Meet Proposed Remission Criteria

    STUDY 014/015 – PROPORTION OF PATIENTS WHO MEET PROPOSED REMISSION CRITERIA N=156 Maintenance Method Criteria n (%) of patients meeting requirement remission criteria P1, P2, P3, P6, G5 ≤ 3 Lieberman et al, 1993 CGI-S «mildly ill»; 8 weeks 43 (27.6%) CGI-C «much improved» Andreasen et al, 2005 P1, P

  16. Slide 16: Study 008A - Design and Key Characteristics

    STUDY 008A - DESIGN AND KEY CHARACTERISTICS Study Population: Study design:  Outpatients with chronic schizophrenia (DMS-5) on therapeutic A potentially pivotal, phase II/III, 4-week, international doses of SGAs who are still symptomatic, despite ≥ 4 weeks of randomized, double-blind, placebo-contr

  17. Slide 17: Study 008A - Usage of Background Antipsychotic Medication

    STUDY 008A - USAGE OF BACKGROUND ANTIPSYCHOTIC MEDICATION Evenamide 30 mg bid Placebo Overall Antipsychotic N=132; n (%) N=159; n (%) N=291; n (%) Risperidone 51 (38.6) 63 (39.6) 114 (39.2) Olanzapine 32 (24.2) 32 (20.1) 64 (22.0) Clozapine 19 (14.4) 17 (10.7) 36 (12.4) Paliperidone 15 (11.4) 24 (15

  18. Slide 18: Study 008A - Most Common TEAEs Based on Evenamide Incidence

    STUDY 008A - MOST COMMON TEAEs BASED ON EVENAMIDE INCIDENCE System Organ Class (SOC) Evenamide 30 mg bid Placebo Overall ≥4.5% on Evenamide N=132; n (%) N=159; n (%) N=291; n (%) Nervous system disorders 9 (6.8) 12 (7.5) 21 (7.2) Psychiatric disorders 6 (4.5) 12 (7.5) 18 (6.2) Gastrointestinal disor

  19. Slide 19: Study 008A - Primary, Key Secondary Efficacy Endpoint – ITT Population

    STUDY 008A - PRIMARY, KEY SECONDARY EFFICACY ENDPOINT – ITT POPULATION PRIMARY ESTIMAND – TREATMENT POLICY, MEAN CHANGE FROM BL – DAY 29 Evenamide 30 mg bid Placebo Scale Visit N=132 N=159 Baseline – mean (SD) 78.4 (4.1) 78.7 (4.0) Day 29 – LS mean (SE) -10.2 (0.7) -7.6 (0.7) PANSS total score LS me

  20. Slide 20: Study 008A - PANSS Total Score

    STUDY 008A - PANSS TOTAL SCORE MEAN CHANGE FROM BASELINE TO DAY 29; ITT POPULATION; PRIMARY ESTIMAND – TREATMENT POLICY; MMRM 0 Evenamide 30 mg bid Placebo -2 N=132 N=159 -4 -6 -7.6 (0.7) Drug-Placebo Difference: -8 LS mean (SE) = -2.5 (0.9) -10 p-value: 0.006 -10.2 (0.7) CI: -4.3, -0.7 -12 Baseline

  21. Slide 21: Study 008A – PANSS Responder Analysis

    STUDY 008A – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) PANSS RESPONDER ANALYSIS – Proportion of patients (%) improving ≥20% from baseline; mITT; OC Evenamide Placebo N=131 N=156 * p-value = 0.037 20.6 OR 1.99 CI (1.0, 3.8) 12.2 11.5 6.9 7.7 4.5 2.3 2.6 Day 8 Day 15 Day 22 Day 29 21 CI=95% confide

  22. Slide 22: Study 008A – Clinical Global Impression of Change (CGI-C)

    STUDY 008A – CLINICAL GLOBAL IMPRESSION OF CHANGE (CGI-C) CGI-C Responder Analysis – Proportion of patients (%) “At least much improved”; mITT * Evenamide Placebo 31.3 N=131 N=156 p-value = 0.006 OR 2.18 CI (1.2, 3.8) 19.8 17.3 11.5 10.9 3.1 3.8 0.6 Day 8 Day 15 Day 22 Day 29 22 CI=95% confidence in

  23. Slide 23: ENIGMA-TRS 1 Placebo-Controlled, 1-Year Study (International)

    ENIGMA-TRS 1 PLACEBO-CONTROLLED, 1-YEAR STUDY (INTERNATIONAL) A Phase III, 52-week, prospective, randomized, double-blind, placebo-controlled, parallel-group, multi-center study, with a primary efficacy endpoint at 12 weeks, to determine the efficacy, KEY SELECTION CRITERIA safety, and tolerability

  24. Slide 24: ENIGMA-TRS 2 Placebo-Controlled, 12-Week Study (US & Selected Countries)

    ENIGMA-TRS 2 PLACEBO-CONTROLLED, 12-WEEK STUDY (US & SELECTED COUNTRIES) Baseline Day 0 ICF Eligibility Randomization 12-week KEY SELECTION CRITERIA  Treatment resistance (TRS) according Screening – 42 days Treatment of 12 weeks to TRRIP working group (Howes et al., 2017)  Antipsychotic treatment

  25. Slide 25: Contact Details

    CONTACT DETAILS NEWRON Stefan Weber – CEO +39 02 6103 46 26 pr@newron.com UK/Europe Germany/Europe Simon Conway, Ciara Martin Anne Hennecke/Caroline Bergmann, FTI Consulting MC Services +44 20 3727 1000 +49 211 52925220 SCnewron@fticonsulting.com newron@mc-services.eu Switzerland USA Valentin Handsc

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