Newron Pharmaceuticals S p A : Report (Corporate May 2024 web2)

COMMITTED TO CNS DRUG DEVELOPMENT

INNOVATIVE TREATMENTS TO IMPROVE QUALITY OF LIFE

Stefan Weber, CEO

German Spring Conference

May 13, 2024

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COMPANY HIGHLIGHTS

Unique portfolio of innovative

CNS product candidates

• Xadago® for Parkinson's disease - Global approvals validate Newron's development capabilities from research to market
• Evenamide - New concept in treating inadequate/non-response in schizophrenia
• Ongoing search for strategically relevant assets

Significant near-term value drivers for leading candidate

Management team with extensive experience and proven track record in drug development and commercialization

Fully funded beyond key value inflection points

• Cash balance of € 12.6 million (Dec. 31, 2023)
• Proceeds from March 14, 2024 subscription agreement: min. € 5.5 up to €15.0* million
• Royalty income, R&D tax credit: approx. €16 m (2 yrs.)

 Cash reach well into 2025

3	* At current roe CHF-EUR

EVENAMIDE - CHANGING THE TREATMENT PARADIGM IN SCHIZOPHRENIA

• Large market opportunity
• Differentiated MoA and positioning
• • First add-on drug
  • • Changes a non-responder into a responder
    • No need to change current therapy, minimizing risk of patient relapse
    • Ease-of-usefor patients & physicians
  • First/only TRS (treatment resistant schizophrenia) drug since/beyond clozapine
  • • 30-50%of total population
    • Opportunity to keep niche indication within TRS for commercialization

• TRS patients: Positive results from 1-year pilot study 014/015 in 161 TRS patients
• NON-TRSpatients: Positive results from pivotal Phase II/III Study 008A
• Next step: Pivotal 1-year study in TRS
• Regulatory strategy: Approval in TRS
• Chance for early market access
• Exclusivity: 2034 (COMP, US) 2033 (COMP, RoW) and beyond (10 yrs exclusivity post approval in the EU)

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HIGH MEDICAL NEED FOR 20 MILLION PATIENTS WORLDWIDE

LARGE MARKET

OPPORTUNITY

(anti-psychotics market >$23bn)

• 1% prevalence of disease
• Disease onset in 20s, need for life-long treatment
• Cost to society (direct cost US only): $63bn p.a.

Over 30 antipsychotics available, but all provide short-term and insufficient relief of some of the symptoms

Most patients with schizophrenia demonstrate reduced control of positive symptoms by typical and atypical antipsychotics after first few years of treatment

Schizophrenia

~30% of patients	+	Patients meeting TRS definition	~30% TRS
respond well to
monotherapy		~40% Inadequate Response
				~70% of patients

Major shortcomings of current antipsychotics:

• No effective drugs to eliminate symptoms, reduce progression, limit disability, suicide or early mortality
• All available options target D2/5HT2, but not glutamate, shown lately to be the major abnormality in poor/non-responders

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EVENAMIDE'S DIFFERENTIATED MOA DEMONSTRATED

Selectively blocks native sodium channels, showing no off-target effect on >130 other CNS receptors, enzymes, transporters, etc.

Selectively blocks VGSCs in a

voltage-anduse-dependent manner

Inhibition of native sodium channels

expressed in rat cortical neurons

Krest (µM)

25

Kinact (µM)

0.4

Modulates sustained repetitive firing

without inducing impairment of the normal neuronal excitability

High frequency		Low frequency
firing		firing
Control		Control

Evenamide 1µM

Evenamide 1µM

Inhibits

Glutamate Release

Evenamide 5 mg/kg ip (n=8)

Evenamide 2.5 mg/kg ip (n=6)

Saline or

Evenamide

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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 approved for inadequately responding patients

Up to 70% of Chronic schizophrenia, non-TRS population (every ~18 months)

Add-on therapy with no dose-limitingside effects a key advantage for patients and prescribers

First drug for treatment of Treatment Resistant Schizophrenia (TRS) since clozapine (1989)

More than 30% of schizophrenia population (with upside to 50%)

in routine practice, the use of clozapine is limited by safety, tolerability, and monitoring requirements

Strong HTA value story to support pricing and coverage

Only option as add-on to clozapine

No antipsychotic has demonstrated benefit as augmenting therapy for clozapine (~30k CLZ-TRS patients in each key territory)

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EVENAMIDE

FIRST POTENTIAL BREAKTHROUGH FOR TRS PATIENTS IN OVER 30 YEARS

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• 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
• Based on above results, and efficacy/safety profile positive health technology assessment opinion is deemed likely
• Low incidence of treatment-emergent adverse events, or drop out due to intolerance
• No pattern of QTc prolongation, cardiac abnormalities, abnormal lab results, or side effects of antipsychotics (EPS, weight gain, sexual dysfunction, hormonal changes, CNS effects)
• > 120 patients treated for 1 year; > 500 unique subjects and > 400 patients with schizophrenia treated with evenamide
• All tox studies (except ERA and carcinogenicity - 1 species, 6 months) accepted by health authorities
• Acceptance of registration dossier based on 1 sufficiently positive TRS

study expected

PILOT STUDY 014/015: DESIGN AND KEY CHARACTERISTICS

Study design:

1. pilot, randomized, open-label,rater-blinded,parallel-group,
   6 weeks, multi-center study followed by an extension up to
   1 year of treatment with evenamide

Objectives:

Evaluate the safety, tolerability and preliminary efficacy of three add-on fixed doses of evenamide (7.5, 15 and 30 mg bid) in patients with treatment resistant schizophrenia (TRS) not responding adequately to their stable, therapeutically active dose of a single antipsychotic medication, treatment for up to 1-yearin the extension study (Study 015)

Efficacy measures: :

PANSS, CGI-S,CGI-C, LOF rated by psychiatrists certified for the study

The efficacy rater was blinded to the dose of evenamide and to any safety findings

Study Population:

• Treatment-Resistance with documented non-response to at least 2 antipsychotics from two different chemical classes including at least one atypical antipsychotic, for at least 6 weeks of treatment each
• PANSS total 70-90; PANSS positive total score ≥ 20, CGI-S of moderately to severely ill (4-6);
• Antipsychotic monotherapy (except clozapine) for 4 weeks prior to screening, with current symptoms present for at least one month
• NO Patients at high risk of suicide/ other psychiatric disorders/ severe or unstable disease

Countries:

India | Italy | Sri Lanka

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STUDY 014/015 - PATIENT DISPOSITION BY STUDY AND DURATION

Randomized		Completed		Discontinued
N = 161		N = 153		N = 8
		Entered		Did not enter
		Extension		extension
		N = 144		N = 9
Day 0
Randomi-		WEEK 6
zation
STUDY 014		STUDY 015
6 weeks		Additional 46 weeks of treatment

Completed		Completed
N = 132		N = 121
Discontinued		Discontinued
N = 12		N = 11

WEEK 30	WEEK 52
6-MONTH	1-YEAR

Total Discontinued	31
Withdrawal of consent	23
Lost to follow-up	5
Adverse event	2
Death	1

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