EQS-Adhoc 119 0 Kommentare Newron announces Half-Year 2021 results - Seite 3

Results from the study are expected by Q4 2022. Newron believes that positive results from this study would qualify the trial as the first adequate and well-controlled (pivotal) study with evenamide in patients with schizophrenia who are inadequate responders to antipsychotics.

Xadago(R)/safinamide
For the continued clinical development of its marketed product Xadago(R)/safinamide, Newron has signed an agreement with its partner Zambon to commence a potentially pivotal study with safinamide in PD LID. This double-blind, placebo-controlled study is intended to be performed in the US, Europe and Asia/Australia, with a potential label extension for safinamide in key markets. Newron currently expects to initiate the study in Q1 2022.

In May, Newron received some Paragraph IV Notice Letters regarding the submission by generic manufacturers of an Abbreviated New Drug Application to the US FDA, seeking approval to engage in the commercial manufacture, use or sale of safinamide mesylate drug product in the US before the expiration of certain US patents. Newron and its partners Zambon and Supernus have responded in filing an infringement suit against the generic manufacturers to secure a 30-month stay of the ANDAs approval, and thus to protect its intellectual property rights relating to Xadago(R)/safinamide tablets. The compound is currently protected by three patents listed in the FDA's Approved Drugs Product List (Orange Book) that expire no earlier than 2027.

Financial Key Takeaways:

For the first six months of 2021, Newron reported a net loss of EUR 9.1 million, compared to EUR 10.5 million in the same period in 2020
Cash used in operating activities has increased to EUR 8.8 million from EUR 7.0 million in H1 2020
Xadago(R) revenues received from Zambon slightly increased from EUR 2.5 million in H1 2020 to EUR 2.7 million in the reporting period
Newron's R&D expenses have fallen to EUR 6.8 million from EUR 7.8 million in H1 2020
G&A expenses were EUR 3.7 million in the first six months of 2021 versus EUR 4.4 million in the same period in 2020
Cash and Other current financial assets at June 30, 2021 were at EUR 21.9 million, compared to EUR 31.3 million at the beginning of the year
Post-period, on September 6, Newron received the fourth tranche of funds under its financing agreement with the EIB that was announced in 2018 and comprised of funding up to EUR 40 million. Tranche 4 consisted of EUR 7.5 million and will primarily be used to support the Company's development programs in CNS diseases