Newron Pharmaceuticals S.p.a. · SIX:NWRN
Newron Pharmaceuticals — FY 2025 Earnings Presentation
38 slides from Newron Pharmaceuticals's earnings presentation, Mar 24, 2026
Slide 1: Committed to CNS Drug Development
COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Full Year Results 2025 and Outlook 2026 Tuesday, March 24, 2026, 2:30 pm CET/1:30 pm UK/9:30 am EDT
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
Slide 3: Full Year Results 2025 and Outlook 2026 Telephone Conference
FULL YEAR RESULTS 2025 AND OUTLOOK 2026 TELEPHONE CONFERENCE Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers: Switzerland/Europe: +41 (0)58 310 50 00 United Kingdom: +44 (0)207 107 0613 United States: +1 (1)631 570 56 13 For other co
Slide 4: 2025 – What a Year!
2025 – WHAT A YEAR ! Evenamide – Schizophrenia • Following the execution of the validating license agreements with EA Pharma / Eisai Group and Myung In Pharm for evenamide in Japan/ Asia and South Korea, and the cashing-in of downpayments and milestones for almost EUR 48 million … • Initiation of pi
Slide 5: 2025 – What a Year (2/3)
2025 – WHAT A YEAR (2/3) Evenamide – Schizophrenia • Publication of impressive study 014/015 and study 008A results in the International Journal of Neuropsychopharmacology and in Therapeutic Advances in Psychopharmacology • Publication of new findings by the University of Pittsburgh in the Internati
Slide 6: 2025 – What a Year (3/3)
2025 – WHAT A YEAR (3/3) Corporate • Initiation of sell-side coverage by four new US and European analysts • Funding • entering into an agreement for the subscription of newly issued shares for proceeds of up to EUR 38 million with a group of existing and new shareholders from Europe and Asia, in Fe
Slide 7: 2026 – What to Expect?
2026 – WHAT TO EXPECT ? Evenamide • 12-week results from pivotal Phase III ENIGMA-TRS program • Evaluation of evenamide in additional indications beyond schizophrenia • Preparation of NDA Dossier Corporate • Strengthening of institutional shareholder base • Preparations for US listing • Upcoming sha
Slide 8: The Evenamide Opportunity
01 THE EVENAMIDE OPPORTUNITY
Slide 9: Transforming Schizophrenia Treatment with Evenamide
TRANSFORMING SCHIZOPHRENIA TREATMENT WITH EVENAMIDE Lead program Evenamide: First-in-class glutamate modulator Addresses 25 Completely Potential first Phase II/III million patients novel MoA add-on therapy clinically worldwide with schizophrenia Modulates glutamate release for TRS or poor responders
Slide 10: 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 10
Slide 11: Evenamide: Significant Efficacy in the MAM Model Points to Long Term Neuroplasticity Effects
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
Slide 12: MAM Model: Evenamide Effects Persist Well Beyond the 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 12
Slide 13: MAM Model: Evenamide Normalizes Social Approach/Interaction Model of Negative Symptoms
MAM MODEL: EVENAMIDE NORMALIZES SOCIAL APPROACH/INTERACTION MODEL OF NEGATIVE SYMPTOMS 10 mins test Sniffing time – social stimulus (s) Toy Total time in the social chamber (s) Total time in the Toy chamber (s) % Entries in the Social chamber Rats tested after 10 min of evenamide injection Toy Chamb
Slide 14: MAM Model: Evenamide Normalizes Social Approach/Interaction Model of Negative Symptoms
MAM MODEL: EVENAMIDE NORMALIZES SOCIAL APPROACH/INTERACTION MODEL OF NEGATIVE SYMPTOMS
Slide 15: MAM Model: Evenamide Normalizes Novel Object Recognition Model of Cognition
MAM MODEL: EVENAMIDE NORMALIZES NOVEL OBJECT RECOGNITION MODEL OF COGNITION Evenamide 3mg/kg, ip 10 min before testing Novel Object Recognition Habituation Aquisition Testing 24h 1h 10min 5min 5min Discrimination index = novel – familiar object exploration - (s) / Novel + familiar object exploration
Slide 16: MAM Model: Evenamide Normalizes Novel Object Recognition Model of Cognition
MAM MODEL: EVENAMIDE NORMALIZES NOVEL OBJECT RECOGNITION MODEL OF COGNITION Sal – Veh = 7 / Sal – Eve = 7 / MAM – Veh = 8 / MAM – Eve = 7 Discrimination index = novel object exploration (s) / Novel + familiar object exploration(s)
Slide 17: Strong Clinical Data
02 STRONG CLINICAL DATA
Slide 18: Evenamide Key Clinical Results Summary
EVENAMIDE KEY CLINICAL RESULTS SUMMARY 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
Slide 19: 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
Slide 20: 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
Slide 21: 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
Slide 22: Study 008A: Significant Symptom Improvement vs. Placebo After Just 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]
Slide 23: 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
Slide 24: Study 008A Estimated Trajectory Beyond Week 4 up to 1-Year
STUDY 008A ESTIMATED TRAJECTORY BEYOND WEEK 4 UP TO 1-YEAR PANSS TOTAL IMPROVEMENT BASED ON STUDY 014/015 RESULTS* 0 008A 40 percentile Median 60 percentile PANSS change from baseline -5 Week 4 6-Month -10.1 • -14.6 1-Year -10 • -16.5 • -16.7 • -19.0 • -19.6 -15 • -22.0 -20 -25 0 6 12 18 24 30 36 42
Slide 25: Study 008A: First Add On Showing Consistent Efficacy Across All Standard 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 (
Slide 26: 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
Slide 27: 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
Slide 28: Pivotal ENIGMA Trials Ongoing
03 PIVOTAL ENIGMA TRIALS ONGOING
Slide 29: ENIGMA-TRS 1: Pivotal 1-Year Phase III Study Evaluating Evenamide as Add-On Therapy in TRS
ENIGMA-TRS 1: PIVOTAL 1-YEAR PHASE III STUDY EVALUATING EVENAMIDE AS ADD-ON THERAPY IN TRS – RECRUITING - 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
Slide 30: ENIGMA-TRS 2: Pivotal 12-Week Study Evaluating Evenamide as Add-On Therapy in TRS
ENIGMA-TRS 2: PIVOTAL 12-WEEK STUDY EVALUATING EVENAMIDE AS ADD-ON THERAPY IN TRS – RECRUITING 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 t
Slide 31: 2026 Congresses
04 2026 CONGRESSES
Slide 32: 2026 Congress Season
2026 CONGRESS SEASON • 2-hour Workshop SIRS 25-29 March 2026 Florence, Italy • 3 Posters accepted • 1 Advisory Board Meeting Prague, Czech EPA 28-31 March 2026 Republic • 3 Posters accepted • 1-hour Symposium CINP 26-29 June 2026 Glasgow, UK • 2 Data Blitz oral presentations • ≥3 Abstracts in prepar
Slide 33: Financial Information AGM/EGM
05 FINANCIAL INFORMATION AGM/EGM
Slide 34: Newron Share Information
NEWRON SHARE INFORMATION LISTING PROFILE AS OF DECEMBER 31, 2025 ANALYST Newron is listed at Sell-side analyst coverage: − SIX since December 2006 and Baader Europe/Dr. Martin Schnee − Since June 26, 2019, traded also at the Dusseldorf Stock HC Wainwright/Raghuram Selvaraju, Ph.D. Exchange (XETRA)
Slide 35: Group Consolidated Financials (IFRS) FY 2025 – Income Statement
GROUP CONSOLIDATED FINANCIALS (IFRS) FY 2025 – INCOME STATEMENT EUR/000 2025 2024 Licence income 8,628 44,470 Royalties 7,770 6,920 Other income 2,728 0 Research and development (15,119) (13,642) expenses General and administrative (8,704) (11,575) expenses Operating profit/(loss) (4,697) 26,173 Fin
Slide 36: Group Consolidated Financials (IFRS) FY 2025 – Balance Sheet and Cash Flow Statements
GROUP CONSOLIDATED FINANCIALS (IFRS) FY 2025 – BALANCE SHEET AND CASH FLOW STATEMENTS EUR/000 2025 2024 Non-current assets 1,976 2,804 Current assets 9,203 51,278 Cash and other financial ass. 28,876 9,826 Total shareholders' equity (11,135) 1,458 Non-current liabilities 1,059 38,944 Current liabili
Slide 37: Annual General Meeting
AGENDA ORDINARY ANNUAL GENERAL MEETING 1. Approval of financial statements as at 31 December 2025 2. Appointment of the members of the Board of Directors for the financial years 2026, 2027 and 2028: 1. Christopher John Martin: as Chairman of the Board and non- DATE executive director; April 23, 2026
Slide 38: 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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