Newron announces H1 2023 results and provides R&D update

Newron announces H1 2023 results and provides R&D update

Milan, Italy, August 4, 2023, 7 am CET – Newron Pharmaceuticals S.p.A. (“Newron”) (SIX: NWRN, XETRA: NP5), a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system, today announced its financial results and operational highlights for the half year ended June 30, 2023, and provided an update on its R&D and business activities.

Highlights H1 2023:

Evenamide

• Results from study 014/015, the first international trial of an antipsychotic new chemical entity (NCE) as an add-on therapy to a single antipsychotic in patients with treatment-resistant schizophrenia (TRS)
  • demonstrated evenamide’s efficacy on multiple measures of psychopathology
  • support movement to potentially pivotal, multinational, randomized, placebo-controlled trial
  • suggest a potential new strategy for the management of TRS patients
• Presentation of data to the medical community at several international psychiatry conferences, highlighting the multi-modal, clinically important response to evenamide in TRS patients, across various domains and multiple timepoints
• Publication of data from study 014/015 in the peer-reviewed International Journal of Neuropsychopharmacology, outlining the continued improvement in symptoms of psychosis in TRS patients receiving evenamide
• Following the publication of this encouraging data, the Company is working towards initiation of study 003, a potentially pivotal, multinational, randomized, double-blind, twelve-week, placebo-controlled study assessing the efficacy, safety and tolerability of evenamide (15/30 mg bid) as an add-on treatment in patients with TRS
• Evenamide (30 mg bid) is also being evaluated as a treatment in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic, in study 008A, a potentially pivotal four-week, randomized, double-blind and placebo-controlled study; patient recruitment is ongoing and on track to report full results by end of 2023/early 2024

Corporate

• As per July 2023, two key promotions strengthening Newron’s senior management team: Laura Faravelli, Director Business Development at Newron since 2019, was promoted to Vice President Business Development, and Roberto Galli, Vice President Finance since 2012, was appointed Chief Financial Officer
• Gillian Dines was elected as a Non-Executive Director to the Board of Newron, following J. Donald (Don) deBethizy stepping down as per the AGM 2023 from the Board after a nine-year tenure
• Implementation of 2023 ESG goals well on track

Stefan Weber, CEO of Newron, commented:

“The first half of 2023 has been a period of enormous progress for Newron. We have reported three striking sets of data from our evenamide development program for treatment-resistant schizophrenia (TRS), presented these results at international psychiatry scientific conferences, and published key results in a peer-reviewed journal. Newron is on track to report more crucial data in the second half of 2023 and early next year from the Phase II study in TRS as well as data from its Phase III trial in non-treatment resistant schizophrenia. Finally, we are progressing towards the initiation of the potentially pivotal study assessing the efficacy, safety and tolerability of evenamide (15/30 mg bid) as an add-on treatment in patients with TRS. The exciting results triggered substantial interest from potential partners on future collaboration opportunities for the development of evenamide.”

Evenamide (Schizophrenia)

In Q1 2023, Newron announced three exciting new sets of data evaluating evenamide as an add-on treatment for patients with TRS.

• In January, the Company presented data from the first 100 patients to complete six months (30 weeks) of treatment with evenamide in study 014/015, the first, international, multi-centre, randomized, open label, rater-blinded study of NCE evenamide (7.5/15/30 mg bid) as an add-on to an antipsychotic (excluding clozapine) in patients with moderate to severe TRS not responding to their current antipsychotic medication
• This announcement was followed in February by further data from the same cohort at the one-year (52 weeks) timepoint
• In March Newron also reported topline data from all 161 patients at the six-week timepoint

Overall, data from study 014 has demonstrated that evenamide was safe and well-tolerated at all doses, with 97% of patients completing six weeks of treatment. The incidence of treatment-emergent adverse events was very low, and more than 90% of the completers chose to continue with evenamide treatment into the long-term extension study (study 015).

The results at the six-week, six-month and one-year timepoints demonstrated a statistically significant improvement of symptoms compared to baseline in patients with TRS after treatment with evenamide. Moreover, comparison of both the six-month and one-year data with the six-week data shows that not only was there a sustained improvement in all key measures of psychosis, but this benefit increased over time. Further evidence of the increasing proportion of patients who experienced a clinically meaningful benefit over time was provided by the proportion of patients considered as “multi-domain-responders”, increasing 2.5-fold from six weeks to 38% at one year. This continued, sustained improvement is unprecedented for an antipsychotic treatment in patients with TRS and demonstrates the potential of evenamide to offer a genuinely innovative therapeutic option for patients struggling with debilitating schizophrenia symptoms who have exhausted other antipsychotic treatments.

Newron presented these data sets at three key conferences in the CNS space during H1 2023; furthermore, they were published in the peer reviewed journal International Journal of Neuropsychopharmacology at the end of the reporting period. The Company will be presenting the full results from extension study 015 of all 161 patients after six months in October at the 36th European College of Neuropsychopharmacology (ECNP) Congress, in Barcelona, Spain, in October.

Newron’s key focus now is on initiating study 003, a randomized, placebo-controlled and potentially pivotal Phase III study of evenamide, which will hopefully confirm its potential as a new add-on for TRS patients. Newron is also investigating evenamide in patients with chronic schizophrenia who experience an inadequate response to their current antipsychotics but who are not classed as having TRS. Study 008A is continuing to enroll patients in this indication, and results are expected by end of 2023/early in 2024.

If approved, evenamide would be the first medication added to existing antipsychotics that improves the symptoms of TRS, offering a much-needed new treatment option for those who are not responding to existing second-generation antipsychotics. Evenamide is revolutionary in its glutamatergic mechanism of action, working through modulation of glutamate and voltage-gated sodium channel blockade. Evenamide modulates sustained repetitive firing, without inducing impairment of normal neuronal excitability, and normalizes glutamate release induced by aberrant sodium channel activity. The results seen validate the rule of glutamate release inhibition in repairing disturbed neural connectivity in the TRS population.

Xadago^®/safinamide (Parkinson’s disease)

In partnership with its partners Zambon and Supernus, Newron continues to further develop and market its product, Xadago®/safinamide. In reference to the receipt of several Paragraph IV Notice Letters in May 2021 regarding the submission by generic manufacturers of an Abbreviated New Drug Application to the US Food and Drug Administration (FDA), seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before expiration of certain US patents, Newron and its partners Zambon and Supernus had filed an infringement case against these manufacturers to secure its intellectual property rights. The companies continue to challenge these submissions and note that the patents on Xadago® (safinamide) tablets remain protected by three patents in the FDA Approved Drugs Product List (Orange Book) until at least 2027.

Financial Summary (IFRS) H1 2023 and H1 2022:

In thousand EUR (except per share information)

Outlook 2023:

The second half of 2023 and early 2024 will bring further crucial data sets and proof points in Newron’s evenamide development program. In the TRS indication, this includes the presentation of full data from all patients in study 014/015 after six months at the ECNP Congress in October, and for the 12 months, as well as the preparations towards initiation of study 003, a potentially pivotal trial. The Company remains on track to report full results from study 008A in patients with chronic schizophrenia who are inadequate responders to their current antipsychotic. Newron’s total available cash resources, in addition to its royalty income and Italian R&D tax credits, will fund the Company’s planned development programs and operations well into 2024.

Newron’s Half-Report 2023 with further details and information is available for download on https://www.newron.com/investors/reports-and-presentation/year/2023

Financial calendar

• Investora 2023, Zurich    September 13-14, 2023
• 36^th ECNP Congress, Barcelona    October 7-10, 2023
• Jefferies 2023 London Healthcare Conference  November 14-16, 2023
• Deutsches Eigenkapitalforum, Frankfurt   November 27-29, 2023

About Newron Pharmaceuticals

Newron (SIX: NWRN, XETRA: NP5) is a biopharmaceutical company focused on the development of novel therapies for patients with diseases of the central and peripheral nervous system. The Company is headquartered in Bresso near Milan, Italy. Xadago^®/safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the UK, the USA, Australia, Canada, Latin America, Israel, the United Arab Emirates, Japan and South Korea, and is commercialized by Newron’s Partner Zambon. Supernus Pharmaceuticals holds the commercialization rights in the USA. Meiji Seika has the rights to develop and commercialize the compound in Japan and other key Asian territories. Newron is also developing evenamide as the potential first add-on therapy for the treatment of patients with symptoms of schizophrenia. For more information, please visit: www.newron.com

For more information, please contact:

Newron
Stefan Weber – CEO, +39 02 6103 46 26, pr@newron.com 

UK/Europe
Simon Conway / Ciara Martin / Natalie Garland-Collins, FTI Consulting, +44 20 3727 1000, SCnewron@fticonsulting.com 

Switzerland
Valentin Handschin, IRF , +41 43 244 81 54, handschin@irf-reputation.ch 

Germany/Europe
Anne Hennecke / Caroline Bergmann, MC Services, +49 211 52925222, newron@mc-services.eu 

USA
Paul Sagan, LaVoieHealthScience, +1 617 374 8800, Ext. 112, psagan@lavoiehealthscience.com

Important Notices

This document contains forward-looking statements, including (without limitation) about (1) Newron’ s ability to develop and expand its business, successfully complete development of its current product candidates, the timing of commencement of various clinical trials and receipt of data and current and future collaborations for the development and commercialization of its product candidates, (2) the market for drugs to treat CNS diseases and pain conditions, (3) Newron’s financial resources, and (4) assumptions underlying any such statements. In some cases, these statements and assumptions can be identified by the fact that they use words such as “will”, “anticipate”, “estimate”, “expect”, “project”, “intend”, “plan”, “believe”, “target”, and other words and terms of similar meaning. All statements, other than historical facts, contained herein regarding Newron's strategy, goals, plans, future financial position, projected revenues and costs and prospects are forward-looking statements. By their very nature, such statements and assumptions involve inherent risks and uncertainties, both general and specific, and risks exist that predictions, forecasts, projections and other outcomes described, assumed or implied therein will not be achieved. Future events and actual results could differ materially from those set out in, contemplated by or underlying the forward-looking statements due to a number of important factors. These factors include (without limitation) (1) uncertainties in the discovery, development or marketing of products, including without limitation difficulties in enrolling clinical trials, negative results of clinical trials or research projects or unexpected side effects, (2) delay or inability in obtaining regulatory approvals or bringing products to market, (3) future market acceptance of products, (4) loss of or inability to obtain adequate protection for intellectual property rights, (5) inability to raise additional funds, (6) success of existing and entry into future collaborations and licensing agreements, (7) litigation, (8) loss of key executive or other employees, (9) adverse publicity and news coverage, and (10) competition, regulatory, legislative and judicial developments or changes in market and/or overall economic conditions. Newron may not actually achieve the plans, intentions or expectations disclosed in forward-looking statements and assumptions underlying any such statements may prove wrong. Investors should therefore not place undue reliance on them. There can be no assurance that actual results of Newron's research programs, development activities, commercialization plans, collaborations and operations will not differ materially from the expectations set out in such forward-looking statements or underlying assumptions. Newron does not undertake any obligation to publicly update or revise forward-looking statements except as may be required by applicable regulations of the SIX Swiss Exchange or the Dusseldorf Stock Exchange where the shares of Newron are listed. This document does not contain or constitute an offer or invitation to purchase or subscribe for any securities of Newron and no part of it shall form the basis of or be relied upon in connection with any contract or commitment whatsoever.