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

Newron Pharmaceuticals — Investor Presentation (February 2024)

26 slides from Newron Pharmaceuticals's investor presentation, February 2024

  1. Slide 1: Committed to CNS Drug Development

    COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Corporate presentation February 2024

  2. Slide 2: Disclaimer

    DISCLAIMER RESTRICTED SCOPE; EXCLUSION OF LIABILITY; CONFIDENTIALITY The information contained in this presentation in respect of Newron Pharmaceuticals S.p.A. ("Newron") and communicated during any delivery of the presentation, including the talks given by the presenters, any question and answer se

  3. Slide 3: Company Highlights

    COMPANY HIGHLIGHTS Differentiated portfolio of innovative Management team with extensive CNS product candidates experience and proven track record  Xadago® for Parkinson’s disease – Global in drug development and approvals validate Newron’s development commercialization capabilities from research t

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

    EVENAMIDE – CHANGING THE TREATMENT PARADIGM IN SCHIZOPHRENIA  Large market  Positive results from phase II Study 002 in  Differentiated MoA and positioning non-TRS patients − First add-on drug  1 of 2 pivotal studies (non-TRS) ongoing − Changes a non-responder into a responder  Pilot study in 1

  5. Slide 5: High Medical Need for 20 Million Patients Worldwide

    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 >$23bn) symptoms

  6. Slide 6: Evenamide's Differentiated MoA Demonstrated

    EVENAMIDE’S DIFFERENTIATED MOA 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-and use-dep

  7. Slide 7: 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 of Only option as add

  8. Slide 8: Evenamide First Potential Breakthrough

    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 FIRST POTENTIAL hospitalization BREAKTHROUGH Based on above r

  9. Slide 9: Overview of Ongoing Studies & Recent Results

    OVERVIEW OF ONGOING STUDIES & RECENT RESULTS TRS EFFICACY RESULTS INDICATE Study 014/015: Open label, pilot, rater blinded study, fixed doses (7.5, 15, and 30 mg bid) in TRS patients, as  Statistically significant improvement from baseline (within add-on to any AP (except clozapine) group analysis,

  10. Slide 10: 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

  11. Slide 11: Study 014/015 – Patient Disposition by Study and Duration

    STUDY 014/015 – PATIENT DISPOSITION BY STUDY AND DURATION Randomized Completed Discontinued Completed Completed Total Discontinued 31 N = 161 N = 153 N=8 N = 132 N = 121 Withdrawal of consent 23 Lost to follow-up 5 Entered Did not enter Discontinued Discontinued N = 12 N = 11 Adverse event 2 Extensi

  12. Slide 12: Study 015 – Summary of Safety Results

    STUDY 015 – SUMMARY OF SAFETY RESULTS Less than 30% of the patients experienced at least one No patient relapsed during one year of treatment with treatment emergent adverse event (TEAE) evenamide Two (2) Serious Adverse Events (SAEs) were reported: Independent Safety Monitoring Board (ISMB): − Deat

  13. Slide 13: Study 015 – Positive and Negative Syndrome Scale (PANSS)

    STUDY 015 – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) MEAN CHANGE FROM BASELINE (SD) – mITT; PRIMARY ESTIMAND TREATMENT POLICY % change from baseline 79.5 (5.04) * 70.0 mITT population, N = 156 -9.5 (7.13) * -11.9% 68.3 * Method 1-Year -11.2 (7.22) 66.5 * Mean change (SD) -14.0% -12.8 (7.65) 63.9

  14. Slide 14: Study 015 – PANSS Responder Analysis

    STUDY 015 – POSITIVE AND NEGATIVE SYNDROME SCALE (PANSS) PANSS RESPONDER ANALYSIS (%) – mITT; PRIMARY ESTIMAND TREATMENT POLICY PANSS Total ≥20% improvement from baseline 84.6 75.2 66.0 52.8 41.8 34.0 24.8 15.4 Week-6 Week-18 6-Month 1-Year Responders Non Responders 14

  15. Slide 15: Clinical Global Impression of Severity of Illness (CGI-S)

    CLINICAL GLOBAL IMPRESSION OF SEVERITY OF ILLNESS (CGI-S) CGI-S MEAN CHANGE FROM BASELINE (SD) % change from baseline 4.5 (0.58) mITT population, N = 156 * Method 1-Year 3.7 * Mean change (SD) 3.6 * -0.8 (0.61) 3.5 Primary Estimand -1.1 (0.69) -1.0 (0.62) -1.1 (0.69) Sensitivity Analysis (LOCF) -1.1

  16. Slide 16: CGI-S Responder Analysis

    CLINICAL GLOBAL IMPRESSION OF SEVERITY OF ILLNESS (CGI-S) CGI-S RESPONDER ANALYSIS (%) Improvement ≥ 2-category from baseline 89,7 85,1 75.9 24.1 14.9 10.3 Week-6 6-Month 1-Year Responders Non Responders

  17. Slide 17: CGI of Change from Baseline (CGI-C) and Level of Functioning (LOF)

    CGI OF CHANGE FROM BASELINE (CGI-C) AND LEVEL OF FUNCTIONING (LOF) CGI-C RESPONDER ANALYSIS (%) LOF MEAN CHANGE FROM BASELINE (SD) At least “Much Improved” 75.6 73.0 69.5 * 62.4 20.4 17.9 +2.4 (3.34) (4.05) 37.6 30.5 24.4 27.0 Week-6 Week-18 6-Month 1-Year Baseline 1-Year N=156 N=127 Responders Non

  18. Slide 18: Patients No Longer Meeting Severity Criteria for TRS

    PATIENTS NO LONGER MEETING SEVERITY CRITERIA FOR TRS 1/2 REQUIREMENTS FOR PATIENTS' ENROLMENT IN STUDY 014/015:  Diagnosis of schizophrenia (DSM-V)  Considered treatment-resistant based on duration of schizophrenia (onset within the past 10 years), and documented failure of treatment on 2 differen

  19. Slide 19: Patients No Longer Meeting Severity Criteria for TRS (mITT; LOCF/OC)

    PATIENTS NO LONGER MEETING SEVERITY CRITERIA FOR TRS (mITT; LOCF/OC) 2/2 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

  20. Slide 20: Remission in Patients with Schizophrenia

    REMISSION IN PATIENTS WITH SCHIZOPHRENIA Remission is defined as a level of symptomology that does not interfere with an individual's behaviour and is also below that required for a diagnosis of schizophrenia* Symptom improvements should last for a minimum of six months in order for remission to be

  21. Slide 21: Criteria for Remission in Patients with Schizophrenia

    CRITERIA FOR REMISSION IN PATIENTS WITH SCHIZOPHRENIA ORIGINAL REQUIREMENTS PROPOSED ADAPTATIONS Lieberman et al., 1993  SADS Impaired understandability  replaced with PANSS P2  Score ≤3 on SADS-C+PD* items: suspiciousness, conceptual disorganization severity of delusions, hallucinations, impaire

  22. Slide 22: Study 014/015 – Proportion of Patients Meeting Remission Criteria

    STUDY 014/015 – PROPORTION OF PATIENTS WHO MEET PROPOSED REMISSION CRITERIA FROM LITERATURE 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 e

  23. Slide 23: Phase III TRS Study – Design

    PHASE III TRS STUDY – DESIGN Baseline Day 0 ICF Eligibility Randomization 12-week 26-week 52-week Screening – 42 days Double-blind treatment of 52 weeks Open-Label Extension ELIGIBILITY PIVOTAL STUDY MAINTENANCE LONG-TERM AP PLASMA LEVELS ENDPOINT ENDPOINT EFFICACY Primary Efficacy Second (long-term

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

    XADAGO IN PARKINSON’S DISEASE MARKETED COMPOUND First approved NCE in >10 yrs (U.S., EU) Globally licensed Double digit/single digit % royalties >€80 milestones/royalties collected 24

  25. Slide 25: Significant Commercial Opportunity in Xadago (Safinamide)

    SIGNIFICANT COMMERCIAL OPPORTUNITY IN XADAGO® (SAFINAMIDE) US / Canada EU Latin America Israel Japan / Asia Australia /New Zealand Launched in US in 2017 Launched in Germany, UK, Italy, Spain and other Approved Launched Launched in Australia Launched in Canada in 2019 EU territories (2015), Switzerl

  26. Slide 26: Contact Details

    CONTACT DETAILS NEWRON Stefan Weber – CEO +39 02 6103 46 26 pr@newron.com UK/Europe Switzerland Germany/Europe USA Simon Conway, Ciara Martin Valentin Handschin Anne Hennecke/Caroline Bergmann, Paul Sagan FTI Consulting MC Services LaVoieHealthScience +44 20 3727 1000 +41 43 244 81 54 +49 211 529252

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