Newron Presents 2023 Financial Results and Provides 2024 Outlook
Ad hoc announcement pursuant to Art. 53 LR
Highlights 2023:
Evenamide (Schizophrenia)
- Compelling efficacy results across multiple investigation timepoints 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 schizophrenia (TRS)
- Presentation of data to the medical community at several international scientific conferences, highlighting the clinically meaningful response to evenamide in TRS patients, across various timepoints
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Publication of data from study 014 and results from first 100 patients of study 015 in peer-reviewed journal, the
International Journal of Neuropsychopharmacology , outlining the continued improvement in symptoms of psychosis in TRS patients treated with evenamide - The findings from study 014/015 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
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Study 008A, a potentially pivotal study of evenamide (30 mg bid) in patients with chronic schizophrenia demonstrating inadequate benefit to their current second-generation antipsychotic, completed patient enrollment; top-line results are expected in
April 2024
Xadago®/safinamide (Parkinson’s disease)
- Newron and its partners reached agreement with generic pharmaceutical manufacturers who submitted Paragraph IV Notice Letters regarding Abbreviated New Drug Applications in the US
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In
Europe , Supplementary Protection Certificates (SPCs) have been approved in most territories of relevance
Corporate
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Newron’s senior management team strengthened by two key promotions:
Laura Faravelli , previously Director Business Development at Newron, was promoted to Vice President Business Development;Roberto Galli , Vice President Finance since 2012, was promoted to Chief Financial Officer -
Gillian Dines appointed as Non-Executive Director to theBoard of Newron at the AGM 2023 -
Margarita Chavez appointed as advisor to theBoard of Newron ; she is nominated for election as Non-Executive Director to the Board at the next Ordinary AGM onApril 17, 2024 - Post-period, Newron entered into an agreement for the subscription of up to 2.05 million newly issued shares with an institutional investor focused on investing in high-growth firms across sectors including biotech and healthcare, to finance the Company’s operations beyond the current key inflection points in its pipeline
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Post-period, agreement with
European Investment Bank (EIB) to extend the near-term tranche repayment dates of Newron’s 2018 financing agreement
Evenamide
Newron made substantial progress across its evenamide development program over the reporting year and into early 2024. The published compelling data is demonstrating the benefit of the Company’s new chemical entity for patients with TRS:
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In Q1 2023, Newron disclosed interim analyses of study 014, a Phase II, international, randomized, open label, rater-blinded trial evaluating evenamide (7.5, 15 or 30 mg bid) as an add-on to a single antipsychotic (excluding clozapine) in patients with moderate to severe TRS, not responding to their current antipsychotic medication, and study 015, its extension to one year of treatment. Results from the first 100 patients to complete six months (30 weeks) of treatment with evenamide were reported in January, followed by results in
February 2023 from the same 100-person cohort at the one-year (52 weeks) timepoint. The results at the six-week, six-month and one-year timepoints demonstrated a clinically important and sustained improvement in symptoms, and importantly, a substantially greater benefit at one-year than at the six-week and six-month datapoints. - Topline data from all 161 patients at the six-week primary endpoint were reported in March. Although the primary objective of the study was safety and tolerability of evenamide, efficacy over baseline was also assessed. The mean Positive and Negative Syndrome Scale (PANSS) total score, Clinical Global Impression of Severity (CGI-S) rating, and the Strauss-Carpenter Level of Functioning (LOF) total score significantly improved compared to baseline (p<0.001). The results from the complete study population of 161 patients were fully consistent with the findings from the first 100 patients at this timepoint. Notably, evenamide was safe and well-tolerated at all doses, with almost all (95%) 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).
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In the beginning of Q4, Newron provided data from the full study population in the extension study (study 015) at the 36th
ECNP Congress inBarcelona, Spain , demonstrating the positive effect of evenamide at six months of treatment. Results showed that benefits continued to accrue over time, and many patients who did not respond early achieved clinically important benefits later on in the study. Remarkably, following treatment with evenamide, approximately 40% of patients at six months no longer met the protocol severity criteria used to diagnose TRS. -
These data were further strengthened, post-period in
January 2024 , with the final results from study 015 reviewing all study participants after one year of treatment. The data showed that treatment with evenamide was associated with sustained, clinically significant benefit that increased throughout the one-year course of treatment. Gradual and sustained improvement was demonstrated across all efficacy scales used. More than 70% of patients experienced clinically important reduction in disease severity. Review of the efficacy data indicated that treatment with evenamide resulted in approximately 50% of patients at one-year no longer meeting any of the protocol severity criteria used to diagnose treatment resistance. Significantly 25% of all patients achieved “remission” (no/minimal symptoms for at least six months), never described before in TRS patients. Moreover, in contrast to common clinical experience, no patient relapsed during the one-year treatment period.
The durability and longevity of these clinical benefits is unprecedented in this indication and suggest that the glutamate modulating effect of evenamide could lead to a progressive and long-standing alteration in brain processes, synergizing with the effect of the antipsychotic to which the patient had become resistant. The next R&D activities will be:
- In their totality, the results from study 014/015 support the initiation of a potentially pivotal Phase III, randomized, double-blind, placebo-controlled study of evenamide as an add-on treatment in patients with TRS, which will hopefully confirm the benefit of evenamide seen so far. If approved, the compound would be the first add-on drug that improves the symptoms of TRS, offering a much-needed new therapeutic option for those who are not responding to existing antipsychotics.
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Newron is also investigating evenamide in a potentially pivotal study (study 008A) in a separate indication, in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Study 008A is a four-week, randomized, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety of evenamide (30 mg bid). Patient enrollment has completed and results from this study are expected in
April 2024 .
Xadago®/safinamide
In partnership with Zambon and Supernus, Newron continued to further develop and market its product, Xadago®/safinamide. In reference to the receipt of several Paragraph IV Notice Letters in
ESG reporting
The Annual Report 2023 provides further transparency on Newron’s corporate ESG commitments. The relevant section covers information on the following topics: employee aspects, environmental aspects including climate, social aspects, human rights, and anti-corruption as well as cyber security – given their relevance to Newron and its stakeholders and given the Company’s ability as a company to have a positive impact on the listed areas. Newron’s 2023 ESG Report follows the most recent edition of the Directive on Information relating to Corporate Governance (Annex 7) of SIX Exchange Regulation (SER).
Financial key takeaways 2023:
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In 2023, Newron reported a net loss of
EUR 16.2 million , slightly lower compared toEUR 17.5 million in 2022 -
Cash used in operating activities has decreased to
EUR 10.1 million fromEUR 11.1 million in 2022 -
Xadago® revenues from Zambon increased from
EUR 6.0 million in 2022 toEUR 9.0 million in the reporting year -
Newron’s R&D expenses have risen to
EUR 13.2 million fromEUR 12.0 million in 2022 -
G&A expenses slightly increased from
EUR 7.4 million in 2022 toEUR 7.5 million -
Cash and Other current financial assets as of
December 31, 2023 were atEUR 12.6 million , compared toEUR 22.8 million at the beginning of the year
Post-period, in
Post-period, and also in
Financial Summary (IFRS) 2023 and 2022:
In thousand EUR (except per share information)
|
2023 |
2022 |
Licence income from contracts with customers |
58 |
14 |
Royalties from contracts with customers |
6,735 |
5,936 |
Other income from contracts with customers |
2,264 |
144 |
Revenue |
9,057 |
6,094 |
Research and development expenses, net |
(13,152) |
(12,005) |
Operating Result |
(11,629) |
(13,302) |
Financial result, net |
(4,571) |
(4,170) |
Net loss |
(16,224) |
(17,493) |
Loss per share |
(0.91) |
(0.98) |
Cash used in operating activities |
(10,140) |
(11,092) |
Cash, cash equivalents and Other current financial assets |
12,599 |
22,774 |
Total assets |
25,866 |
37,195 |
Newron’s Annual Report 2023 is available for download on the Company’s website at: www.newron.com/investors/reports-and-presentation/year/2023
Outlook 2024:
Following the remarkable evenamide data to date, Newron plans to initiate a potentially pivotal trial evaluating evenamide in TRS, once preparations are completed and a partner has been identified. If this trial replicates the data published in study 014/015, the Company believes there will be substantial improvements in the treatment paradigm and outlook for TRS patients. Newron is also primed to report data from study 008A, a potentially pivotal study assessing evenamide in schizophrenia patients not deemed to be treatment resistant. If positive, this would be the first well-controlled study to demonstrate the clinical utility of evenamide in schizophrenia patients who show an inadequate response to treatment with atypical antipsychotics.
Newron is continuing to have a productive dialogue with industry players around potential future collaboration opportunities for evenamide. The Company also continues to review the CNS landscape for opportunities to expand its drug development pipeline.
Newron’s total available cash resources together with the initial proceeds deriving from the subscription agreement signed post-period, will fund the Company’s planned development programs and operations well into 2025 and well beyond the current key value inflection points in our pipeline.
Media/analyst/investor Conference Call today at
Newron’s management team will present today the 2023 full-year results and provide an update and guidance for 2024. Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers:
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Switzerland /Europe : +41 (0)58 310 50 00 -
United Kingdom : +44 (0)207 107 0613 -
United States : +1 (1)631 570 5613
The presentation is available at www.newron.com/investors/reports-and-presentation/year/2023
2024 Shareholders’ Meeting Agenda:
Newron’s Board of Directors has approved the below agenda for the
The agenda is as follows:
Ordinary part
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Approval of the financial statements as at
31 December 2023 . Update – as per art. 2447 Civil Code - regarding the freezing of 2022 Newron’ standalone losses. Connected and consequent resolutions; -
Appointment of a new members of the Board of Directors, for the financial years 2024 and 2025 and, therefore, until the approval of the financial statements as of
December 31st, 2025 , as follows:- determination of the relevant number,
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proposal to appoint
Margarita Chavez *, in quality of new non-executive director - Determination of the remuneration
Connected and consequent resolutions.
Extraordinary part
- Proposal to amend Art 14 of the by-laws. Related and consequential resolutions;
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Proposal of attribution to the Board of Directors of powers, pursuant to art. 2443 of the Civil Code, exercisable during the next 5 years, to increase the share capital, in one or more times, for a maximum amount of
Euro 357.636,00 , in addition to any premium, with or without option rights, pursuant to art. 2441, paragraphs 1 and/or 4, first and second part, and/or 5, 6 of the Civil Code. Related and consequential resolutions; -
Proposal of attribution to the Board of Directors of powers, pursuant to art. 2443 of the Civil Code, exercisable during the next 5 years, to increase the share capital, in one or more times, for a maximum amount of
Euro 107.291,00 , in addition to any premium, with exclusion of the option rights, pursuant to art. 2441, paragraphs 5, 6 and/or 8 of the Civil Code, for one or more stock option plans. Related and consequential resolutions;
*
Financial calendar
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AGM and EGM 2024:
April 17, 2024 -
Half-year report 2024:
September 19, 2024
About
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
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
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