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

Newron Pharmaceuticals — Investor Presentation (November 2025)

35 slides from Newron Pharmaceuticals's investor presentation, November 2025

  1. Slide 1: Committed to CNS Drug Development

    COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Company presentation| November, 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 Proven expertise in CNS drug development  Xadago® − Global approvals in Parkinson’s disease validate Newron’s development capabilities from research to market  Evenamide − Only add-on- compound with scientific evidence of efficacy in treating poorly responding/treatment resistan

  4. Slide 4: The Evenamide Opportunity

    01 THE EVENAMIDE OPPORTUNITY

  5. Slide 5: Transforming Schizophrenia Treatment with Evenamide

    TRANSFORMING SCHIZOPHRENIA TREATMENT WITH EVENAMIDE Lead program Evenamide: First-in-class glutamate modulator Addresses 25 Potential first Completely Phase II/III million patients add-on therapy novel MoA clinically worldwide with schizophrenia for TRS or poor responders Modulates glutamate release

  6. Slide 6: Transforming Schizophrenia Treatment with Evenamide (II)

    TRANSFORMING SCHIZOPHRENIA TREATMENT WITH EVENAMIDE (II) PIVOTAL LANDMARK PHASE III STRONG PARTNER FOR JAPAN/ASIA, ENIGMA-TRS program underway further opportunities in discussion ENIGMA-TRS 1 EA Pharma Myung In Pharm 52-week, ≥600 patients, add-on to SGAs (incl. (Eisai Group) (South Korea) clozapine

  7. Slide 7: Schizophrenia – High Medical Need for 23 Million Patients Worldwide

    SCHIZOPHRENIA – HIGH MEDICAL NEED FOR 23 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 >

  8. Slide 8: Evenamide – Differentiation & Commercial Opportunity in Schizophrenia

    EVENAMIDE – DIFFERENTIATION & 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 Potential to be first add-on First drug for Treatment Resistant Only known* optio

  9. Slide 9: 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-

  10. Slide 10: Ketamine-Induced Deterioration of PPI Rescued by Clozapine and Evenamide Combination

    KETAMINE-INDUCED DETERIORATION OF PPI IS RESCUED BY COMBINATION OF INEFFECTIVE DOSES OF CLOZAPINE AND EVENAMIDE 80 Impairment “Full reversal” P<0.001 CLO Evenamide FGAs/SGAs 60 3 mg/kg ip ^^^ + *** %PPI Average EVE EVE 40 1.25 mg/kg po 5.0 mg/kg po CLO *** 3 mg/kg ip Combination of ineffective doses

  11. Slide 11: 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 11

  12. Slide 12: Evenamide: Significant Efficacy in the MAM Model

    EVENAMIDE: SIGNIFICANT EFFICACY IN THE MAM MODEL POINTS TO LONG TERM NEUROPLASTICITY EFFECTS DOMAIN KEY FINDINGS ON EVENAMIDE Reduces Hippocampal Pyramidal Neuron Hyperactivity Normalizes VTA Dopamine Neuron Population Activity Neuronal Activity Impacts Primarily Lateral VTA Dopamine Effects of Even

  13. Slide 13: MAM Model: Evenamide Effects Persist Beyond Drug Half-Life

    MAM MODEL: EVENAMIDE EFFECTS PERSIST WELL BEYOND THE DRUG HALF- LIFE THIS IMPLIES INDUCTION OF LONG-TERM PLASTICITY AFTER A SINGLE DOSE 13

  14. Slide 14: Strong Phase II/III Data Package

    02 STRONG PHASE II/III DATA PACKAGE

  15. Slide 15: Study 014/015: Design and Key Characteristics

    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 least

  16. Slide 16: Phase II Study 014/015: Patient Disposition by Study and Duration

    PHASE II STUDY 014/015: PATIENT DISPOSITION BY STUDY AND DURATION Randomized Completed Entered extension Completed Completed N = 161* N = 153 (95%) N = 144 (89%) N = 132 (82%) N = 121 (75%) 7.5/15/30 mg bid N=50/60/51 Discontinued Did not enter Discontinued Discontinued N=8 extension N = 9 N = 12 N

  17. Slide 17: Study 015: 1-Year PANSS Data Confirm Unique Long-Term Benefit

    STUDY 015: 1-YEAR PANSS DATA CONFIRM UNIQUE LONG-TERM BENEFIT OF EVENAMIDE 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 Evenamide treatm

  18. Slide 18: Study 015: Responder Rate Nearly Triples Over 1 Year

    STUDY 015: RESPONDER RATE NEARLY TRIPLES OVER 1 YEAR OF TREATMENT PANSS RESPONDER ANALYSIS (%) – mITT PANSS Total ≥ 20% Improvement from baseline 84.6 66.0 58.2 41.8 34.0 15.4 Week-6 6-Month 1-Year Responder Non Responder The proportion of patients achieving a clinically meaningful (≥20%) improvemen

  19. Slide 19: Study 015: Nearly 50% No Longer Met TRS Criteria After 1 Year

    STUDY 015: NEARLY 50% NO LONGER MET TRS CRITERIA AFTER 1 YEAR 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 (39.4) 83 (53.2) 76

  20. Slide 20: Study 014/015: Up to 28% of Patients Achieved Sustained Remission

    STUDY 014/015: UP TO 28% OF PATIENTS ACHIEVED SUSTAINED REMISSION 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, P2, P3, N1,

  21. Slide 21: Phase III Study 008A: Design and Key Characteristics

    PHASE III 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, plac

  22. Slide 22: Study 008A: Study Design and Key Features

    STUDY 008A: STUDY DESIGN AND KEY FEATURES Week 4 Safety Day 0/1 Endpoint Follow up Day 8 Day 15 Day 22 (+ 30 days) 21-day Screening Period Antipsychotic plasma RANDOMIZATION levels to confirm Evenamide (30 mg bid) adherence Placebo Patients receiving second–generation antipsychotics (APs) at therape

  23. Slide 23: Study 008A: Favorable Safety & Tolerability Comparable to Placebo

    STUDY 008A: FAVORABLE SAFETY & TOLERABILITY COMPARABLE TO PLACEBO System Organ Class (SOC) ≥4.5% on Evenamide Evenamide 30 mg bid N=132; n (%) Placebo N=159; n (%) Overall 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

  24. Slide 24: Study 008A: Significant Symptom Improvement vs. Placebo After 4 Weeks

    STUDY 008A: SIGNIFICANT SYMPTOM IMPROVEMENT VS. PLACEBO AFTER JUST 4 WEEKS 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 mean difference (SE) -2.5 (0.9) p-value [CI] 0.006 [-4.3, -0.7]

  25. Slide 25: Study 008A: Significant PANSS Improvement vs. Placebo After 4 Weeks

    STUDY 008A: SIGNIFICANT PANSS IMPROVEMENT VS. PLACEBO AFTER 4 WEEKS PANSS 80 MEAN CHANGE FROM BASELINE TO DAY 29; ITT POPULATION; PRIMARY ESTIMAND – TREATMENT POLICY; MMRM Drug-Placebo Difference: LS mean (SE) = -2.5 (0.9) p-value: 0.006 75 CI: -4.3, -0.7 - 7.6 (0.7) Placebo = therapeutic dose of SG

  26. Slide 26: Study 008A: First Add-On Showing Consistent Efficacy Across Antipsychotics

    STUDY 008A: FIRST ADD ON SHOWING CONSISTENT EFFICACY ACROSS ALL STANDARD ANTIPSYCHOTICS Evenamide 30 mg bid Placebo N=132 N=159 Antipsychotic PANSS change from PANSS change from n (%) n (%) baseline (SD) baseline (SD) Risperidone 51 (38.6) -8.8 (6.5) 63 (39.6) -7.3 (7.4) Olanzapine 32 (24.2) -13.4 (

  27. Slide 27: Study 008A: Responder Rate vs. Placebo After 4 Weeks Nearly Doubled

    STUDY 008A: RESPONDER RATE VS. PLACEBO AFTER 4 WEEKS NEARLY DOUBLED PANSS RESPONDER ANALYSIS – Proportion of patients (%) improving ≥20% from baseline; mITT; OC p-value = 0.037 20,6 * OR 1.99 CI (1.0, 3.8) 12,2 11,5 6,9 7,7 2,3 2,6 4,5 Day 8 Day 15 Day 22 Day 29 Evenamide Placebo N=131 N=156 A signi

  28. Slide 28: Study 008A: Clinician-Rated Improvement Nearly Doubled vs. Placebo at Day 29

    STUDY 008A: CLINICIAN-RATED IMPROVEMENT NEARLY DOUBLED VS. PLACEBO AT DAY 29 CGI-C RESPONDER ANALYSIS – Proportion of patients (%) “At least much improved”; mITT p-value = 0.006 31,3 * OR 2.18 19,8 CI (1.2, 3.8) 17,3 11,5 10,9 3,1 3,8 0,6 Day 8 Day 15 Day 22 Day 29 Evenamide Placebo N=131 N=156 A si

  29. Slide 29: Pivotal ENIGMA Trials Ongoing

    03 PIVOTAL ENIGMA TRIALS ONGOING

  30. Slide 30: ENIGMA-TRS 1: Pivotal 1-Year Phase III Study in TRS

    ENIGMA-TRS 1: PIVOTAL 1-YEAR PHASE III STUDY EVALUATING EVENAMIDE AS ADD-ON THERAPY IN 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 CRITE

  31. Slide 31: ENIGMA-TRS 2: Pivotal 12-Week Study in TRS

    ENIGMA-TRS 2: PIVOTAL 12-WEEK STUDY EVALUATING EVENAMIDE AS ADD-ON THERAPY IN TRS 12-Week KEY SELECTION CRITERIA ICF Baseline Day 0 Eligibility  Treatment resistance (TRS) according Randomization to TRRIP working group (Howes et al., 2017) Screening – 42 days 12 weeks  Antipsychotic treatment as p

  32. Slide 32: Summary

    04 SUMMARY

  33. Slide 33: Evenamide Results Summary: Efficacy

    EVENAMIDE RESULTS SUMMARY: EFFICACY Sustained and robust Phase III confirms Favorable safety CLINICAL EXPOSURE efficacy over one year Phase II results and tolerability profile  1-year Phase II study de-  4-week Phase III study  Low incidence of monstrated permanent confirmed Phase II findings tre

  34. Slide 34: Key Takeaways: A Clear Path to Value Creation

    KEY TAKEAWAYS: A CLEAR PATH TO VALUE CREATION Evenamide:  First-in-class glutamate modulator with compelling Strong clinical Phase II/III efficacy & safety data foundation, global A transforma-  Addresses large, underserved TRS population partnerships, and tive, de-risked with no approved add-on t

  35. Slide 35: 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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