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

Newron Pharmaceuticals — 21st Baader Helvea Swiss Equities Conference (January 2025)

25 slides from Newron Pharmaceuticals's conference presentation, Jan 10, 2025

  1. Slide 1: Committed to CNS Drug Development

    COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Stefan Weber, CEO 21st Baader Helvea Swiss Equities Conference Bad Ragaz, January 10, 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 – Validation by EA Pharma/Eisai Partnering Agreement

    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: 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-

  8. Slide 8: Straight to the Heart of the Brain

    STRAIGHT TO THE HEART OF THE BRAIN HIPPOCAMPUS evenamide Site of deficit Ventral Striatum Ventral current antipsychotics Pallidum VTA Dopamine Dopamine Receptors 8

  9. Slide 9: 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

  10. Slide 10: Evenamide: First Potential Breakthrough for TRS Patients

    EVENAMIDE Differentiated – structure, pharmacology, benign side effect profile, indication (Add-on to any antipsychotic for TRS patients), NO competitor identified Evenamide treatment of 161 TRS patients prevented ANY psychotic relapse or hospitalization FIRST POTENTIAL Placebo-controlled study in 2

  11. Slide 11: 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

  12. Slide 12: 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 12

  13. Slide 13: 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 (

  14. Slide 14: Study 014/015 – Proportion of Patients Meeting 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

  15. Slide 15: 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

  16. Slide 16: Evenamide: First Evidence of Benefit of Add-on Therapy

    EVENAMIDE Evenamide add-on treatment in patients with chronic schizophrenia not responding FIRST EVIDENCE adequately to their current antipsychotic OF BENEFIT OF An international, randomized, double-blind, placebo-controlled trial: ADD-ON THERAPY pivotal study 008A IN INADEQUATE RESPONDERS Enrollmen

  17. Slide 17: 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

  18. Slide 18: 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 18 CI=95% confide

  19. Slide 19: Study 008A – CGI-C Responder Analysis

    STUDY 008A – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) 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 19 CI=95% confidence in

  20. Slide 20: Study 008A – Summary of Efficacy Results

    STUDY 008A – SUMMARY OF EFFICACY RESULTS – MEAN CHANGE FROM BASELINE TO ENDPOINT Efficacy Parameter/ Analysis/ Population LS Mean Difference (SE)* 95% CI p-value PANSS Total Score -2.5 (0.90) -4.3, -0.7 0.006 MMRM (Primary Estimand Treatment Policy) ITT Population CGI-S MMRM -0.16 (0.08) -0.3, -0.0

  21. Slide 21: Study 008A – Summary of Efficacy Results – Responder Analyses

    STUDY 008A – SUMMARY OF EFFICACY RESULTS – RESPONDER ANALYSES Efficacy Parameter/ Analysis/ Responders Odds Ratio Responder Category p-value* Population [n/N (%)] (95% CI) PANSS ≥ 20% improvement EVE: 27/131 (20.6) OC (mITT N as denominator) 1.99 (1.0, 3.8) 0.037 from baseline PBO: 18/156 (11.5) mIT

  22. Slide 22: Evenamide Key Findings from Study 008A

    EVENAMIDE Study 008A results indicate that the primary (PANSS) and the key secondary (CGI-S) KEY FINDINGS endpoints required by regulators for a pivotal study were met and showed significant FROM STUDY 008A superiority compared with the benefits observed in patients on placebo Benefit with Evenamide

  23. Slide 23: Upcoming Pivotal (Phase III) Placebo-Controlled 1-Year Study in TRS

    UPCOMING PIVOTAL (PHASE III), PLACEBO-CONTROLLED, 1-YEAR STUDY IN PATIENTS WITH TRS 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 saf

  24. Slide 24: Xadago - Marketed Compound in Parkinson's Disease

    XADAGO - MARKETED COMPOUND IN PARKINSON’S DISEASE First approved NCE in >10 yrs (U.S., EU) Globally licensed Double digit/single digit % royalties >€85 million milestones/royalties collected 24

  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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