Newron Pharmaceuticals S.p.a. · SIX:NWRN
Newron Pharmaceuticals — FY2023 Earnings Presentation
28 slides from Newron Pharmaceuticals's earnings presentation, Mar 19, 2024
Slide 1: Committed to CNS Drug Development: Full Year Results 2023 and Outlook 2024
COMMITTED TO CNS DRUG DEVELOPMENT INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE Full Year Results 2023 and Outlook 2024 Tuesday, March 19, 2024, 3:00 pm CET
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 2023 and Outlook 2024 Telephone Conference
FULL YEAR RESULTS 2023 AND OUTLOOK 2024 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 Speakers: St
Slide 4: 2023 - Resistance melting away (1/3)
2023 - Resistance melting away (1/3) Evenamide – Schizophrenia • Compelling efficacy results across multiple investigation time points up to and including one-year from study 014/015 evaluating evenamide as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophreni
Slide 5: 2023 - Resistance melting away (2/3)
2023 - Resistance melting away (2/3) Evenamide – Schizophrenia • Study 014/015 results support the initiation of a potentially pivotal, Phase III, randomized, double-blind, placebo-controlled study with evenamide as an add-on treatment in patients with TRS • Potentially pivotal Study 008A with evena
Slide 6: 2023 - Resistance melting away (3/3)
2023 - Resistance melting away (3/3) Corporate • Laura Faravelli promoted to Vice President Business Development • Roberto Galli promoted to Chief Financial Officer • Gillian Dines appointed as NED at AGM 2023 • Margarita Chavez appointed as advisor to the Board; nominated for election as NED at AGM
Slide 7: Company Highlights
COMPANY HIGHLIGHTS Unique 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 to market
Slide 8: 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) completed − Changes a non-responder into a responder patient enrollme
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 of Only option as add
Slide 10: 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
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
Slide 12: 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
Slide 13: 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
Slide 14: 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 14
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) * * 3.8 3.6 * -0.7 (0.71) -1.0 (0.62) 3.5 -1.1 (0.69) Baseline Week-6 6-Month 1-Year N=156 N=152 N=131 N=127 * p-value vs baseline < 0.001, paired t-test, OC 15
Slide 16: CGI-S Responder Analysis
CLINICAL GLOBAL IMPRESSION OF SEVERITY OF ILLNESS (CGI-S) CGI-S RESPONDER ANALYSIS (%) Improvement ≥ 2-category from baseline Responders Non Responders 89,7 85,1 75,9 24,1 14,9 10,3 Week-6 6-Month 1-Year 16
Slide 17: 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” * Responders Non Responders 20.4 17.9 +2.4 (3.34) 75,6 (4.05) 69,5 62,4 37,6 30,5 24,4 Week-6 6-Month 1-Year Baseline 1-Year N=156 N=127 * p-val
Slide 18: Patients No Longer Meeting Severity Criteria for TRS
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 (39.4) 83 (53
Slide 19: 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
Slide 20: 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
Slide 21: 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-ter
Slide 22: 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 million milestones/royalties collected 22
Slide 23: Newron Share Information
NEWRON SHARE INFORMATION LISTING PROFILE AS OF DECEMBER 31, 2023 ANALYST Newron is listed at Sell-side analyst coverage: − SIX since December 2006 and Baader Helvea/Leonildo Delgado − Since June 26, 2019, also at the Dusseldorf Stock Exchange and traded on XETRA Newron issues ordinary shares (no
Slide 24: Group Consolidated Financials (IFRS) FY 2023 – Income statement
Group Consolidated Financials (IFRS) FY 2023 – Income statement EUR/000 2023 2022 Licence income 58 14 Royalties 6,735 5,936 Other income 2,264 144 Research and development (13,152) (12,005) expenses General and administrative (7,534) (7,391) expenses Operating loss (11,629) (13,302) Net loss (16,22
Slide 25: Group Consolidated Financials (IFRS) FY 2023 – Balance sheet and Cash flow statements
Group Consolidated Financials (IFRS) FY 2023 – Balance sheet and Cash flow statements EUR/000 2023 2022 Non-current assets 6,214 8,702 Current assets 7,053 5,719 Cash and other financial ass. 12,599 22,774 Total shareholders' equity (29,908) (14,030) Non-current liabilities 26,848 46,184 Current lia
Slide 26: Agenda – AGM April 17, 2024
AGM April 17, 2024 – 10.00 am CET - Newron premises AGENDA ORDINARY 1. Approval of the balance sheet as at 31 December, 2023 Connected and consequent resolutions 2. Appointment of Margarita Chavez as member of the Board of Directors for the years 2024-2025 EXTRAORDINARY 1. Proposal to amend Art. 14
Slide 27: Q&A
Q&A
Slide 28: 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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