Newron announces 2020 financial results and provides outlook for 2021
Milan, Italy, March 16, 2021 – 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 year ended December 31, 2020, and provided an outlook for 2021.
All evenamide pre-clinical studies requested by the US Food and Drug Administration (FDA) have been completed with no toxicity concerns identified
Despite the COVID-19 pandemic, the Company has successfully completed enrolment for explanatory study 008 with evenamide in patients with schizophrenia, with results expected by the end of March 2021
Newron remains on track to initiate its pivotal Phase III program in Q3 2021 and continues to evaluate potential options for partnering/co-developing evenamide
Xadago®/safinamide (Parkinson’s disease)
Newron noted that Supernus Pharmaceuticals acquired the CNS portfolio of US WorldMeds, including the US rights to Xadago®/safinamide, effective June 2020
Agreement signed with Zambon for potentially pivotal study with safinamide in patients suffering from Parkinson’s disease levodopa-induced dyskinesia (PD LID)
Newron continues to evaluate opportunities to broaden its pipeline of treatments for central and peripheral nervous system diseases
The Company received third tranche of EUR 7.5 million out of a potential EUR 40 million total funding amount under its financing agreement with the European Investment Bank (EIB)
Cash (incl. Other current financial assets) as of December 31, 2020 is EUR 31.3 million
Stefan Weber, CEO of Newron, commented:
“The onset of the COVID-19 pandemic in 2020 presented enormous challenges for societies across the world. The healthcare industry, in particular, was challenged with identifying the resources to cope with the pandemic and with finding ways to fight it. We are proud of the way that Newron has adapted to this fast-evolving situation and of our ability to continue making operational progress, despite the pandemic and the difficulties it presents. 2020 has demonstrated that Newron’s business remains resilient, and we move into 2021 and beyond confident in our strategy for the future. In addition, we enter into this year assessing a number of exciting strategic opportunities and additional compounds to expand our pipeline of novel therapies, and we will update the market accordingly.”
Present treatments are unsatisfactory for most people suffering from schizophrenia and some 30% of patients with schizophrenia do not respond adequately to conventional therapy. Evenamide, as potentially the first add-on therapy to currently marketed antipsychotics, holds promise to change the treatment management paradigm: improving functioning and allowing patients to continue longer on their maintenance antipsychotic treatment. This would likely translate into lower rates of relapse, thus helping reduce the personal, societal, and economic burden to patients, their families, and society. In the reporting year, Newron made significant progress with evenamide for the treatment of patients with inadequately treated or clozapine treatment-resistant schizophrenia. The additional short-term pre-clinical explanatory studies with evenamide requested by the US FDA were successfully completed, and no toxicity concerns were identified.
Additionally, Newron has initiated explanatory study 008, a clinical study designed to evaluate the safety, tolerability, electroencephalography (EEG) effects and preliminary efficacy of two fixed doses of evenamide in outpatients suffering from chronic schizophrenia receiving treatment with a second-generation atypical antipsychotic. Despite anticipated delays associated with the COVID-19 pandemic, the study was ongoing during 2020 and in January 2021, Newron announced that enrolment has been completed with 138 patients randomized to treatment with placebo, 7.5 mg BID, or 15 mg BID of evenamide at study centers in the US and India. Results from this four-week, randomized, double-blind placebo-controlled study are expected by the end of March 2021.
Newron remains on track to initiate the Phase III studies with evenamide in Q3 2021, contingent on no delays due to COVID-19 restrictions. The proposed Phase III clinical trial program with evenamide targets patients with schizophrenia experiencing worsening of psychosis while on atypical antipsychotics, and treatment-resistant patients not responding to clozapine. The latter represents an orphan-like indication with approximately 25,000 patients in the US (with similar numbers in the EU).
Newron’s partner Zambon had previously held discussions with the US FDA on the design of a potentially pivotal study to evaluate the efficacy of the compound in Parkinson’s disease patients with levodopa induced dyskinesia (PD LID). The intention is to perform the study in centers in the US, Europe, and Asia/Australia, aiming at a label extension for PD LID in key global markets. Given Newron’s extensive experience in the development of Xadago®/safinamide, Newron and Zambon have agreed on Newron taking responsibility for conducting the study. Zambon will remain associated with the study; Newron and Zambon will share the cost of the study equally, and Newron will qualify for a one-time milestone payment and a greater share of royalties, should the outcome of the trial lead to a label extension. Newron is currently working on finalizing the design of the study with international clinical experts and regulatory authorities.
To date, safinamide has received marketing authorization for the treatment of Parkinson’s disease in the European Union, Switzerland, the United Kingdom, the United States, Canada, Australia, countries in Latin America, Israel, the United Arab Emirates, Japan and South Korea. It is commercialized by Newron’s partner Zambon, their partners, and Meiji Seika and Eisai under the brand names Onstryv® in Canada, Equfina® in Japan and South Korea, and Xadago® in the rest of the world.
Financial Key takeaways 2020:
In 2020, Newron reported a net loss of EUR 21.0 million, compared to EUR 20.2 million in 2019
Cash used in operating activities has been reduced to EUR 15.6 million from EUR 22.0 million in 2019
Xadago® royalty income increased by 10% to EUR 5.2 million versus EUR 4.8 million in 2019, when a one-time milestone payment for approval in Japan of net EUR 2.0 million was incurred, on top
Newron’s net R&D expenses have seen a reduction to EUR 14.9 million from EUR 17.4 million in 2019, largely due to the termination of the development program in Rett syndrome.
Due to substantial changes of the regulations covering the Italian R&D tax credits, the Company could only accrue an additional EUR 1.4 million in 2020 versus EUR 5.0 million in 2019. The cumulated tax credits of EUR 15.9 million can be offset with future tax and social contribution payments by Newron
In 2020, G&A expenses have been reduced to EUR 8.1 million compared to EUR 9.9 million in 2019
Cash and Other current financial assets at December 31, 2020, were at EUR 31.3 million, compared to EUR 39.2 million at the beginning of the year.