27 June 2024

This report has been issued for information purposes only and is not intended to constitute investment advice. It is based on estimates and forecasts of third parties regarding revenues, earnings, and business developments. Such estimates and forecasts cannot be independently verified by reason of the subjective character. Newron Pharmaceuticals S.p.A. gives no guarantee, representation, or warranty and is not responsible or liable as to its accuracy and completeness.

Please see important research disclosures at the end of this document

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June 2024

27 June 2024

VALUATIONLAB

FINANCIAL ANALYSIS

NEWRON PHARMACEUTICALS

FOCUS AREA: DISEASES OF THE CENTRAL NERVOUS SYSTEM (CNS) AND ORPHAN DISEASES

KEY DATA

SIX: NWRN

MARKET CAPITALIZATION (CHF MN)

147

PRICE ON 27 JUNE 2024

8.3

ENTERPRISE VALUE (CHF MN)

135

RISK-ADJUSTED NPV PER SHARE (CHF)

17.3

CASH (31 DECEMBER 2023) (CHF MN)

12

UPSIDE/DOWNSIDE (%)

109%

MONTHLY OPERATING EXPENSE (CHF MN)

1.4

RISK PROFILE

HIGH RISK

CASH RUNWAY (YEAR)

WELL INTO 2025

SUCCESS PROBABILITY LEAD PIPELINE DRUG

65%

BREAK-EVEN(YEAR)

2024*

EMPLOYEES (GROUP)

22

FOUNDED (YEAR)

1998

LISTED (YEAR)

2006

KEY PRODUCTS:

STATUS

MAJOR SHAREHOLDERS:

(%)

- XADAGO (PARKINSON'S DISEASE)

MARKETED

- ZAMBON GROUP

4.4

- EVENAMIDE (NON-TREATMENT-RESISTANT SCHIZOPHRENIA - NON-TRS)

POSITIVE PHASE II/III

- EUROPEAN INVESTMENT BANK

3.7

- EVENAMIDE (TREATMENT-RESISTANT SCHIZOPHRENIA (TRS) INCL. CTRS**)

POC ESTABLISHED

- EXECUTIVE MANAGEMENT

0.6

- FREE FLOAT

99.4

- AVERAGE TRADING VOLUME (30-DAYS)

122'864

UPCOMING CATALYSTS:

DATE

ANALYST(S):

BOB POOLER

- EVENAMIDE - PARTNERING AGREEMENT

BEFORE START "STUDY 017"

BP@VALUATIONLAB.COM

- PUBLICATION OF H1 2024 RESULTS

19 SEPTMEBER 2024

+41 79 652 67 68

- EVENAMIDE - START PIVOTAL "STUDY 017" IN TRS^ PATIENTS

Q4 2024

* ASSUMES PARTNERING EVENAMIDE IN 2024; **CTRS = CLOZAPINE TREATMENT-RESISTANT SCHIZOPHRENIA

SOURCE: VALUATIONLAB ESTIMATES, NEWRON PHARMACEUTICALS

ESTIMATES AS OF 27 JUNE 2024

A pivotal year

KOLs highlight evenamide's potential at Investor Day

Newron Pharmaceuticals has a product pipeline that targets diseases of the peripheral & central nervous system (CNS) and rare diseases. Key value drivers include 1) Xadago, a once-daily oral add-on therapy for Parkinson's disease with a unique dual mechanism of action, launched in the EU (2015), US (2017), and Japan (2019), and 2) evenamide, an add- on therapy for schizophrenia and treatment-resistant schizophrenia (TRS), including CTRS (clozapine treatment-resistant schizophrenia, an orphan-like indication). With cash and current financial assets of EUR 12.6 mn (31 December 2023), increasing Xadago revenues, Italian R&D tax credits, and a recent share subscription by an institutional healthcare investor, Newron sees a cash runway well into 2025. The company is adequately funded beyond its key value inflection points, including the first of two potentially pivotal phase II/III trials with evenamide in schizophrenia and TRS. We derive a sum-of-partsrisk-adjusted (r)NPV value of CHF 17.3 per share, with 8% of the value related to Xadago, 89% to evenamide, and 3% to cash. Newron's risk profile is High Risk as the company is loss- making with revenues only from Xadago royalties in Parkinson's disease.

Key catalysts:

  • Partnering evenamide with a major CNS player (before starting "Study 017"): Out- licensing evenamide to a major CNS player in return for substantial upfront, regulatory, and sales milestones and royalties on sales extends the cash runway substantially and can be used to in-license new CNS compounds and sell evenamide in CTRS through a small in-house commercial team of key account managers in the US.
  • Publication of H1 2024 results (19 September 2024): These results may coincide or follow shortly after the announcement of a global or regional partner for evenamide, providing more information on the development and commercialization plans.
  • Start pivotal "Study 017" trial of evenamide in TRS (Q4 2024): this marks the second potentially pivotal phase III trial needed for approval of evenamide in schizophrenia, including (clozapine) treatment-resistant schizophrenia; our success rate increases to 50% (phase II/III trial) from 35% (POC established) resulting in an increase of our rNPV by CHF 1.0 per share.

Please see important research disclosures at the end of this document

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27 June 2024

Flash Update

NYC Investor Day highlights evenamide's unique positioning in schizophrenia

On June 25th, 2024, Newron hosted an Investor Day event in New York City, USA, highlighting the unique positioning of its key late-stage schizophrenia drug, evenamide, including clinical, scientific, registrational, and commercial plans for chronic and treatment- resistant schizophrenia. Three key opinion leaders (KOLs) in neuroscience and schizophrenia reviewed the company's clinical trials for evenamide and explored the high unmet needs, new concepts, and recent neurobiological findings for treating poor responders and patients with treatment-resistant schizophrenia (TRS). Evenamide's unique mechanism of action targets the core abnormalities in schizophrenia patients and should benefit poor-responding and TRS patients with a long-lasting effect and excellent tolerability, underlining its blockbuster sales potential.

The highlights of the Investor Day underlining evenamide's unique positioning in schizophrenia include:

  • New insights into evenamide's novel MOA targeting the site of dysfunction
  • Compelling phase III "Study 008A" trial results in poorly responding patients with schizophrenia
  • Exciting POC "Study 014/015" trial results in treatment-resistant schizophrenia
  • Outline of new phase III "Study 017" trial in TRS patients
  • Partnering agreement expected in the next few months

Novel MOA targets site of dysfunction, normalizing activity without bad side effects Dr. Anthony Grace, Ph.D., Editor-in-Chief of the International Journal of Neuropsychopharmacology, Distinguished Professor of Neuroscience, and Professor of Psychiatry and Psychology at the University of Pittsburgh, presented breakthrough preclinical data on treatment-resistant schizophrenia (TRS), which affects around 30% of patients. Most marketed antipsychotics act through the dopaminergic/serotoninergic pathways. However, these antipsychotics appear to not act directly on the site of dysfunction in schizophrenia, leading to poor response, treatment resistance, early mortality, and tolerability issues. There is little evidence for a primary deficit in the dopaminergic system, and drugs that target this system do not impact the full spectrum of schizophrenia pathology.

It is now believed the dopaminergic system itself is normal but is likely to be dysregulated by other structures, such as the hippocampus, which is hyperactive in schizophrenia and the primary site of dysfunction. The hippocampus is a major component of the brain and part of the limbic system and plays an important role in memory, learning, and emotion. Dopamine agonists compensate for the dopaminergic system overactivity but are working five connections downstream from the site of dysfunction. This leads to significant side effects, which underly non-compliance and treatment resistance. This class of drugs is also ineffective in negative and cognitive symptoms and in treatment-resistant schizophrenia.

Evenamide acts at the site of dysfunction, the hippocampus. By selectively normalizing only hyperactive hippocampus neurons, it can normalize activity without introducing significant side effects. Because evenamide acts on the hippocampus, it can also normalize dysfunction not only regarding the dopamine system and psychosis but also impact negative

Please see important research disclosures at the end of this document

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27 June 2024

and cognitive symptoms. Evenamide's glutamate modulation has produced dramatic effects in the MAM model of schizophrenia, which closely mimics the changes observed in patients with schizophrenia. In this model, evenamide reversed abnormal hippocampal neuronal activity, normalized dopamine neuron population activity, improved cognition, and normalized social interactions. By acting on the glutamate system, evenamide can alleviate symptoms in patients who are treatment-resistant to dopaminergic-acting antipsychotic drugs. The effects of evenamide outlast its presence in the brain, suggesting that it impacts long-term plasticity changes and may help with neuronal repair in its extended therapeutic actions.

Unique "Study 008A" results provide hope for poorly responding patients

Dr. John Kane, M.D., Co-Director and Professor of the Institute of Behavioural Science, Feinstein Institutes for Medical Research, and Professor of Psychiatry, Donald and Barbara Zucker School of Medicine at Hofstra/Northwell, discussed the compelling positive results of the potentially pivotal phase III "Study 008A" trial results of evenamide, which offer new hope for poorly responding and treatment-resistant schizophrenia patients

More than 20 mn people worldwide are affected by schizophrenia. Despite over 60 different types of atypical and typical antipsychotics used for schizophrenia globally, a considerable number of patients remain severely ill and resistant to treatment. At the onset of illness, rates of primary treatment resistance have been shown up to 23%. Overall, 10-30% of patients have little or no response to current antipsychotics, and up to an additional 30% of patients have partial response to treatment. This may be because there are biological changes in the brains of patients that show reduced benefit and non-response to treatments compared to patients who respond adequately to treatment. First-episode patients (FEP) who show reduced or no response to their antipsychotics are highly likely to be diagnosed with TRS later. Significant neuro-anatomical and neurochemical differences can be detected in at-risk mental state (ARMS), FEP, and TRS compared to healthy controls and antipsychotic responders. Proton-MRI spectral studies indicate higher striatal glutamate levels in FEP and TRS patients compared to responders. Patients who are poor responders are likely to relapse significantly more than patients who respond to medication. To date, there are no studies that have demonstrated that the addition of one antipsychotic to another, or switching antipsychotics, has produced any benefit to poor responders and TRS patients.

Evenamide is the first drug to show benefit in this difficult-to-treat patient population, as seen in the potentially pivotal phase III "Study 008A" trial in 291 patients with chronic schizophrenia who respond poorly to second-generation antipsychotics. The primary endpoint, the Positive and Negative Syndrome Scale (PANSS), and the key secondary endpoint, the Clinical Global Impressions Scale - Severity (CGI-S), were met and showed statistical significance compared to placebo. The benefit of evenamide appears to be distributed equally among the seven second-generation antipsychotics, including clozapine, allowed in the trial. This therapeutic benefit may derive from evenamide's glutamate modulation activity. Evenamide was extremely well tolerated, without any of the usual side effects of available antipsychotics. The side effect profile is like a placebo with no increase in EPS, weight gain, blood glucose, metabolic syndrome, sexual dysfunction, CNS or cardiac effects, or laboratory abnormalities.

Please see important research disclosures at the end of this document

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Exciting "Study 014/015" shows sustained and continuous improvement in TRS

Dr. Stephen R. Marder, M.D., a Distinguished Professor of Psychiatry at the Semel Institute of Neuroscience & Human Behavior and Director of the Section on Psychosis at UCLA Neuropsychiatric Institute, discussed the exciting results of the proof-of-conceptopen-label "Study 014/015" of evenamide in patients with treatment-resistant schizophrenia (TRS).

An estimated one-third of patients with schizophrenia are treatment-resistant. Patients may initially respond to treatments, but 30-60% become partially responsive or resistant to treatment. The use of higher doses (10-30% of patients), the addition of another antipsychotic (20-40% of patients), or switching to another drug is unsuccessful in patients with TRS. Clozapine remains the only drug approved for TRS, but for a variety of reasons (e.g., myocarditis, seizures, agranulocytosis) is grossly underutilized and used in less than 5% of patients. At least 50% of patients will improve substantially with clozapine. A high portion of patients - 30 to 50% - receiving both clozapine and other antipsychotics meet the criteria for TRS.

Evenamide, with its unique mechanism of action, has shown promising results as an add- on therapy to antipsychotics in the open-label4-weekproof-of-concept (POC) "Study 014" trial and its one-year extension "Study 015" trial, which can reduce the severity of psychosis symptoms that are resistant to treatment to with current antipsychotics including clozapine. The placebo-controlled "Study 014" trial showed effectiveness after only 4 weeks of treatment.

The "Study 015" extension trial suggests that evenamide has a unique property in that the TRS patients showed continuing improvement across all efficacy measures over a one-year treatment period. This has never been shown before in TRS patients. Similarly, the conversion of TRS patients to a non-resistant state and the finding that 25% of patients met criteria for remission are remarkable and unprecedented. This justifies further evaluation of evenamide in a new phase III, placebo-controlled,one-year global trial in TRS patients who are receiving other antipsychotics. Dr. Marder will be the Principal Investigator of this trial, dubbed "Study 017".

An outline of the late-stage clinical development for evenamide in TRS

Newron's Chief Medical Officer, Ravi Anand, MD, provided an update on evenamide's clinical program, outlining that evenamide's promising results will be evaluated in a global phase III, randomized, double-blind,one-year trial dubbed "Study 017. The trial will be conducted in the US, Canada, and in several countries in Asia, Europe, and Latin America. More than 900 TRS patients are expected to be screened with more than 600 patients randomized 1:1 to evenamide 15-30 mg twice-daily (BID) or placebo. The primary efficacy endpoint will be the change from baseline in PANSS scores at 12 weeks. Following this initial period, subjects will continue on their assigned treatment until week 26, for the second maintenance efficacy endpoint, and then on to 1 year for read-out of the third (one-year,long-term) efficacy endpoint. The long-term extension will also serve to evaluate the long- term safety and tolerability of evenamide. For carcinogenicity, one study with a 6-month duration in genetically modified mice will be conducted in parallel to "Study 017".

An agreement has been made with the regulatory authorities for approval of evenamide in TRS based upon positive "Study 017" trial results if supported by significant results from an additional positive phase III trial, namely, "Study 008A". The registration dossier and new drug application (NDA) could be filed prior to completion of "Study 017" with 1,500 patients

Please see important research disclosures at the end of this document

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27 June 2024

(an ICH requirement). Newron is confident that "Study 017" should meet its objectives and will be available as a treatment for schizophrenia patients based on the sustained and continuing improvement across all efficacy measure seen all clinical trials such as the POC trial "Study 014/015" and pivotal phase III "Study 008A" trial with a superior safety and tolerability profile.

Lucrative partnering deal with a major CNS player before starting "Study 017" in Q4 Based on the positive topline results of the first potentially pivotal trial, "Study 008A" of evenamide in chronic schizophrenia patients who inadequately respond to current antipsychotic therapy and the unprecedented findings of the "Study 014/015" trial in TRS, Newron expects to sign a partnering agreement for evenamide in the next few months. This could be a global licensing agreement with a major CNS player or a licensing agreement for non-strategic regions, excluding the US in Japan, both in return for substantial upfront, regulatory, and sales milestones and royalties on sales.

This should substantially strengthen the company's cash position with the potential to in- license external CNS and rare disease clinical compounds. We assume Newron will sell evenamide in the CTRS orphan indication in the lucrative US market through a small in- house commercialization team of key account managers to optimize its long-term value. Following the partnering agreement, the company expects to start the second pivotal "Study 017" of evenamide in TRS in Q4 2024.

Please see important research disclosures at the end of this document

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Investment case, strategy & cash

Investment case in a nutshell

Newron's key driver, evenamide for schizophrenia, continues to provide compelling data with "Study 008A", the first potentially pivotal phase II/III trial in chronic schizophrenia patients who inadequately respond to second-generation antipsychotics, meeting its primary endpoint and key secondary endpoint. This follows exciting one-year efficacy data in treatment-resistant schizophrenia (TRS) in the phase II "Study 014/015" trial. Newron will submit these results and the protocol for the second pivotal "Study 017" trial in TRS patients to the FDA. "Study 017" in TRS patients is now planned to start in Q4 2024. Both should add significantly to the value while substantially increasing the success rate and reducing the clinical development risk. On the back of the positive pivotal "Study 008A" results and the unprecedented results of "Study 014/015", a (global) partnering deal with a major CNS player is expected to be signed before the start of "Study 017" in Q4 2024, providing further equity upside. Hence, we believe substantial equity upside should be unlocked in 2024.

Based on our detailed bottom-up forecasts for Newron's key drivers, which have ample patent life and market exclusivity and target blockbuster markets, we conservatively calculate a sum-of-the-partsrisk-adjusted NPV of CHF 308 mn or CHF 17.3 per share, providing equity upside of 109% from the current share price.

Life Cycle Positioning - High Risk

We qualify Newron's risk profile as High Risk as the company still makes losses, and revenues depend solely on Xadago in Parkinson's disease. On reaching breakeven in 2024 (assuming a significant agreement for evenamide in schizophrenia with substantial upfront payments) and the successful completion of the pivotal development of evenamide in schizophrenia and CTRS, the company should see a re-rating of the risk profile to Medium Risk. (See Important Disclosures for our Risk Qualification).

LIFE CYCLE POSITIONING - SIX-LISTED BIOTECHNOLOGY COMPANIES

RESEARCH & DEVELOPMENT PHASE

RETURN PHASE

EXPIRY

SAFETY

ANIMALS

~10s

-PRECLINICAL

PHASE

I

ADDEX

0

MOLECULAR PT.

SUCCESS

<5% ~10%

DOSE

~ 100s

<-----

PHASE II

CURATIS

SPEXIS

10% -45%

EFFICACY / APPROVAL

COSMO

BIO-SIMILARS

~ 100s - 1,000s PTS

p<0.05

BASILEA

SALES

PARTNERING

---->

KUROS BIO.

III

NEWRON

PHASE

SANTHERA

GENERICS

~ 8-14

BREAKEVEN

20

YEARS

RELIEF TH.

REGISTRATION

COSTS

IDORSIA

40% - 65%

~80%

"STAR"

"CASH COW"

"MATURE"

"DOG"

ß RISK-ADJUSTED DISCOUNTED CASH FLOW

à

P/E >20x

P/E ~10-15x

P/E > 6-10x

P/E ~ 15x

SOURCE: VALUATIONLAB

Please see important research disclosures at the end of this document

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Italian biopharmaceutical company specializing in CNS and rare diseases

Newron Pharmaceuticals S.p.A. is an Italian biopharmaceutical company specializing in prescription drugs to treat peripheral & central nervous system (CNS) disorders and rare, so-called orphan diseases, with expertise in ion channel blockers, an important class of CNS drugs. Newron is based in Bresso, near Milan, Italy, and was established in December 1998 as a spin-off from Pharmacia & Upjohn (now part of Pfizer). In 2014, the company opened a US office in Morristown, New Jersey, USA. Currently, the group has 23 employees. Newron was listed on the SIX Swiss Stock Exchange in 2006 with the ticker code "NWRN". In addition to the primary listing in Switzerland, Newron began trading in Germany on the Düsseldorf Stock Exchange and XETRA (ticker code "NP5") to facilitate access for investors based in the EU via EU brokers in 2019.

Strategy to develop CNS drug to an optimal value, then out-licensemajor indications and preferably market orphan indications by an own small specialist salesforce Newron's strategy is to develop drugs originated from earlier discovery capabilities, acquire or in-license CNS disease drugs and develop them to their optimal value, and in case of rare diseases like evenamide in clozapine treatment-resistant schizophrenia (CTRS), whenever possible, commercialize them to optimize long-term value. Where necessary or advantageous, the company seeks co-development and commercialization agreements to reduce research and development costs and generate revenue through R&D funding, milestone payments, and royalties on future sales.

Newron's pipeline consists of a nice mix of major and rare disease indications Newron's pipeline consists of a nice mix of major indications, such as Xadago, which already generates revenues through its partners in Parkinson's disease, and evenamide as an add- on to antipsychotics in schizophrenia, and an orphan-like indication, such as evenamide in CTRS (clozapine treatment-resistant schizophrenia) with a high unmet medical need. Substantial value will be unlocked with the approval and launch of evenamide in schizophrenia with blockbuster sales potential. Newron's individual products include:

  • Evenamide - A new paradigm in schizophrenia, transformational potential Evenamide is Newron's pipeline project with the highest peak sales potential, targeting a USD 12 bn schizophrenia market, and will be transformational for Newron upon approval. In 2017, evenamide established proof-of-concept (POC) as an add-on to current antipsychotics in patients with schizophrenia. The compound is being developed as an add-on treatment for 1) non-treatment-resistant schizophrenia (non-TRS) patients experiencing inadequate response to current atypical antipsychotic monotherapy and 2) treatment-resistant schizophrenia (TRS) patients who are not responding adequately to any second-generation antipsychotics, including the orphan-like indication clozapine treatment-resistant schizophrenia (CTRS), covering roughly 70% of schizophrenia patients. Approximately 30% of schizophrenia patients respond well to monotherapy.
    Health authorities (Spain, Denmark, Sweden, Germany, UK, CHMP, US, Canada) have agreed with the current phase III development program for evenamide in schizophrenia. In 2021, Newron provided additional informative trials requested by the FDA before starting phase III development. The preclinical part of the safety work was completed and submitted to the FDA with no toxicity issues reported. The first 4-week clinical safety (EEG - electroencephalogram) trial dubbed "Study 008" in 138 patients was completed in March 2021, with no safety issues.

Please see important research disclosures at the end of this document

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"Study 014/015": In January 2024, unprecedented topline results were presented of the open-label (unblinded) phase II "Study 014/015" safety and dose-ranging trial of evenamide (twice daily 7.5 mg, 15 mg, or 30 mg evenamide, no placebo) as an add-on to current antipsychotics (excluding clozapine) in 161 patients suffering from TRS. This was the final safety requirement by the FDA before starting phase III development in schizophrenia.

"Study 008A": On 30 April 2024, positive topline results were reported of the first potentially pivotal phase II/III "Study 008A" trial of evenamide in 291 non-TRS patients in Europe, Asia, and Latin America. Evenamide met its primary endpoint, a statistically significant reduction in the PANSS Total Score, and its key secondary endpoint, the CGI- S scale, after only 4 weeks of evenamide treatment on top of current antipsychotic therapy, including clozapine. Its favorable safety and tolerability profile was confirmed.

"Study 017": Newron plans to start the potentially pivotal phase III "Study 017" trial of evenamide in TRS patients in Q4 2024. Newron plans to recruit roughly 15-20% of clozapine treatment-resistant schizophrenia (CTRS) patients to address this orphan-like population. If the exceptional results seen in "Study 014/015" are replicated, approval of evenamide in TRS could follow swiftly based on this single pivotal trial alone. Evenamide could become the first drug for TRS since clozapine in 1989.

Co-developmentand commercialization partner: The company plans to out-license evenamide to global and/or local CNS players for substantial upfront, regulatory, and sales milestones and royalties on sales. This is expected to occur before the start of the pivotal "Study 017" in Q4 2024. Newron would like to commercialize evenamide in CTRS in the lucrative US market to optimize the long-term value, as limited marketing resources are required for this niche indication.

  • Xadago - First product to reach market - sales uptake hampered by generics Xadago (safinamide) is Newron's first-ever approved drug for treating patients with mid- to-late-stage Parkinson's disease and was launched by its partners in the EU in 2015 and in the US in 2017 and in Canada (branded Onstryv) and Japan (branded Equfina) in 2019. Xadago stems from Newron's earlier ion channel discovery capabilities and is the first New Chemical Entity (NCE) approved and launched for treating Parkinson's disease in over a decade. The company receives sales royalties and milestone payments from its development and commercialization partners Zambon (worldwide rights excluding Meiji Seika territories) and Meiji Seika (Japan and Asia). Uptake in the lucrative US market (marketed by Supernus Pharma) is hampered by widespread cheap generic versions of Teva's Azilect (rasagiline), which belongs to the same drug class as Xadago. In 2021, several generic manufacturers filed Paragraph IV ANDA's for Xadago in the US. Newron and its partners Zambon and Supernus have reached a settlement agreement with the generic manufacturers, allowing them to enter the US market no earlier than 1 December 2027. Supplementary Protection Certificates (SPCs) have been approved in most major markets, and Newron is confident these will be granted in all key territories, providing protection until 2029.

Newron sufficiently funded into 2025 beyond key value inflection points.

With EUR 12.6 mn in cash and short-term investments (31 December 2023), increasing royalty payments on Xadago sales, Italian R&D tax credits (approximately EUR 16 mn in the next 2 years), the recent share subscription agreement with an institutional healthcare

Please see important research disclosures at the end of this document

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investor with up to EUR 15 mn in funding, and the deferral of the repayment of the first three tranches of the EUR 40 mn EIB loan by roughly 1 ½ years now starting in November 2025, Newron expects to be sufficiently funded well into 2025 beyond key value inflection points.

Following the positive topline results of the pivotal trial "Study 008A" and unprecedented "Study 014/015" topline results, Newron is evaluating potential options for partnering or co- developing evenamide in schizophrenia to share the development risk, reduce the cash burn, and replenish its cash position. This will increase financial flexibility, which can be used to broaden the pipeline with promising external CNS compounds.

Newron's key priorities in the next 12-18 months include:

  • The continued rollout of Xadago in Parkinson's disease by its partners in new countries/areas and contracting new commercialization/distribution partners for Xadago beyond the EU, US, Japan, and Asia.
  • Submit the pivotal phase II/III "Study 008A" trial results of evenamide in schizophrenia to the US and EU regulators.
  • Submit the exciting "Study 014/015" trial results to the FDA to address the remaining safety issues and finalize the protocol for the pivotal "Study 017" trial of evenamide in TRS.
  • Determine potential options for global or local partnering or co-development and commercialization of evenamide before the start of the pivotal "Study 017".
  • Start the second pivotal "Study 017" trial of evenamide in TRS patients in Q4 2024
  • Seek new CNS development projects to replenish the company's development pipeline.

Please see important research disclosures at the end of this document

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June 2024

Attachments

Disclaimer

Newron Pharmaceuticals S.p.A. published this content on 28 June 2024 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 28 June 2024 07:50:22 UTC.