Newron Announces 2022 Financial Results and Provides Outlook For 2023
Ad hoc announcement pursuant to Art. 53 LR
Highlights 2022:
Evenamide (Schizophrenia)
- Striking interim efficacy and safety results from world-first Phase II clinical trial evaluating evenamide as add-on therapy for patients with treatment-resistant schizophrenia (TRS), after six weeks and, post-period, six months and one year
-
Enrolment of patients in study 014 completed, with 161 subjects randomized (post-period); full results from the study after six weeks of treatment expected in
March 2023 - Following the interim data in patients suffering from TRS, study 003, a potentially pivotal, multinational, randomized, double-blind, ten-week, placebo-controlled study assessing the efficacy, safety and tolerability of 15 and 30 mg bid of evenamide as an add-on treatment in patients with TRS, is expected to commence in 2023
- Patient recruitment in potentially pivotal study 008A to evaluate evenamide in patients with chronic schizophrenia who are not classed as treatment resistant is ongoing, results from the study are expected in 2023
Xadago®/safinamide (Parkinson’s disease)
- Newron and its partners Zambon and Supernus continue to work to protect intellectual property rights associated with Xadago®/safinamide in the US, responding to Paragraph IV Notice Letters regarding Abbreviated New Drug Applications submitted from generic pharmaceutical manufacturers
Corporate
- Newron continues its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide. The company also continues to explore a number of potential opportunities to expand its pipeline in central nervous system diseases
-
Gillian Dines proposed for election as new member to the Board of Directors at the AGM onApril 18, 2023 -
Development of ESG strategy completed, with focus areas and objectives for 2023 – Reporting will be based on 10 out of the 17
Sustainable Development Goals , as defined by the UN
“The last twelve months have been an exciting period for our Company, particularly given the announcement of three sets of compelling interim efficacy results from our ongoing Phase II clinical study 014/015 with evenamide in patients with treatment-resistant schizophrenia (TRS). We have also made significant progress with the Phase III study of evenamide (study 008A) in another indication – patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who are not classed as having TRS – and have strengthened both our management team and our Environment, Social and Governance (ESG) efforts”.
Evenamide
In
Post-period, in Q1 2023, Newron was able to announce interim data from study 014 as well as its extension arm, study 015, showing results in the first 100 patients in the study after six months (30 weeks) and one year (52 weeks) of treatment with evenamide:
-
In
January 2023 , Newron announced six-month interim data which demonstrated a continued improvement in TRS symptoms following treatment with evenamide, as well as a substantially greater proportion of patients experiencing a meaningful improvement when compared to six weeks of treatment. -
Closely following, in
February 2023 , the Company disclosed one-year interim data from study 014/015. Results provided further striking new evidence of the sustained efficacy of the addition of evenamide to antipsychotics in TRS patients by demonstrating substantially greater benefit at one year than noted at the six-week and six-month datapoints.
These results after six months and one year were highly compelling, statistically significant (paired t-test), and clinically meaningful, as not only was evenamide well tolerated with few adverse effects, but there was a sustained and continued improvement at all doses. Newron was particularly struck by data suggesting there is a continued improvement over time in these measures. While recognizing that this study has no control arm, clinically meaningful improvements over baseline in key efficacy measures after one year are, to the Company’s knowledge, unprecedented in patients with diagnosed TRS.
The enrolment of study 014 has now been completed with 161 subjects. The Company expects to announce the full results from this study still in
Study 003 is planned to be a potentially pivotal, multinational, randomized, placebo-controlled, ten-week global study to assess the efficacy, safety and tolerability of evenamide (15/30 mg bid) as an add-on treatment in outpatients with treatment-resistant schizophrenia (TRS) not responding adequately to their monotherapy treatment with atypical antipsychotics (including clozapine). Positive data from this study would confirm the potential of evenamide as the first medication that could be added to an antipsychotic and improve symptoms of TRS in patients. Newron plans to initiate this study in 2023.
Alongside the R&D-work with evenamide in TRS, the Company is also conducting study 008A, a four-week, randomised, double-blind and placebo-controlled study assessing the efficacy, tolerability, and safety (including electroencephalogram effects) of evenamide (30 mg bid) in patients with chronic schizophrenia currently being treated with a second-generation antipsychotic, but who demonstrate an inadequate response to that treatment. Recruitment at treatment centers in
Xadago®/safinamide
In partnership with 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
Newron and Zambon have reached an agreement to discontinue their plans to initiate a clinical study with safinamide in Parkinson’s disease patients with levodopa-induced dyskinesia (PD LID). As a matter of settlement, Zambon will advance an undisclosed fee to Newron.
ESG commitment and reporting
Sustainability is one of the most crucial current challenges, for every company, regardless of size or industry. Newron has already issued several policies and procedures and taken some specific actions that are part of ESG best practices, but in 2022 the strategic process started formally with a materiality analysis in close dialogue with internal and external stakeholders to best understand how each one of them could relate with relevance of all the possible areas to Newron’s ESG efforts. An ESG strategy based on a key materiality review has been developed, and
Financial Key takeaways 2022:
-
In 2022, Newron reported a net loss of
EUR 17.5 million , compared toEUR 14.9 million in 2021 -
Cash used in operating activities has decreased to
EUR 11.1 million fromEUR 11.4 million in 2021 -
Xadago® revenues from Zambon increased from
EUR 5.8 million in 2021 toEUR 6.0 million in the reporting period -
Newron’s R&D expenses have risen to
EUR 12.0 million fromEUR 10.7 million in 2021 -
G&A expenses were stable at
EUR 7.4 million -
Cash and Other current financial assets as at
December 31, 2022 , were atEUR 22.8 million , compared toEUR 34.6 million at the beginning of the year
Financial Summary (IFRS) 2022 and 2021:
In thousand EUR (except per share information)
|
|
2022 |
|
2021 |
|
|
|
Licence income from contracts with customers |
14 |
|
34 |
|
|
|
Royalties from contracts with customers |
5,936 |
|
5,728 |
|
|
|
Revenue |
6,094 |
|
5,762 |
|
|
|
Research and development expenses, net |
(12,005 |
) |
(10,725 |
) |
|
|
Operating Result |
(13,302 |
) |
(12,357 |
) |
|
|
Financial result, net |
(4,170 |
) |
(2,527 |
) |
|
|
Net loss |
(17,493 |
) |
(14,901 |
) |
|
|
Loss per share |
(0.98 |
) |
(0.84 |
) |
|
|
Cash used in operating activities |
(11,092 |
) |
(11,445 |
) |
|
|
Cash, cash equivalents and Other current financial assets |
22,774 |
|
34,594 |
|
|
|
Total assets |
37,195 |
|
50,486 |
|
Newron’s Annual Report 2022 is available for download on the Company’s website: www.newron.com/investors/reports-and-presentation/year/2022
Outlook 2023:
The Company anticipates that 2023 will be another exciting year, with further clinical updates from its evenamide program. Following the striking six-month and one-year results in TRS, Newron is continuing its dialogue with industry partners around potential future collaboration opportunities for the development of evenamide and to potentially expand its pipeline of CNS drugs.
Newron looks forward to presenting the full results from study 014 with evenamide in
Newron’s total available cash resources will fund the Company’s planned development programs and operations well into 2024.
2023 Shareholders’ Meeting Agenda:
Newron’s Board of Directors has approved the below agenda for the
The full invitation and supporting material will be made available on the Company’s website (www.newron.com/investors/shareholders-meeting) on the same date. The agenda is as follows:
1. Approval of the balance sheet as at
2. Appointment of the members of the Board of Directors, for the financial years 2023, 2024 and 2025 and, therefore, until the approval of the financial statements as of
2.1. determination of the relevant number,
2.2. proposal to appoint:
-
Ulrich Köstlin in quality of Chairman of the Board and non-executive director; -
Stefan Weber , in quality of executive director; -
Patrick Langlois in quality of non-executive director; -
Luca Benatti in quality of non-executive director; and, -
Gillian Dines in quality of non-executive director*.
2.3. Determination of the remuneration of the Board of Directors. Connected and consequent resolutions.
*
Dial-in details to the media/analyst/investor conference call on
Newron’s management team will present the 2022 full-year results and provide an update and guidance for 2023.
Please dial in five to ten minutes prior to the beginning of the call using one of the following telephone numbers:
or connect to the webcast
Participants’ Link: https://media.choruscall.eu/mediaframe/webcast.html?webcastid=hMiCgav4
The investor presentation is available on 14 March as of
Financial calendar
-
AGM 2023:
April 18, 2023 -
Half-year report 2023:
September 14, 2023
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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