Newron Pharmaceuticals (NWRN) H1 2024 earnings summary

Executive summary

• Achieved major clinical milestones for evenamide in treatment-resistant and chronic schizophrenia, with significant efficacy and safety demonstrated in Phase II and pivotal studies.

• Hosted an Investor Day highlighting evenamide's potential and ongoing partnership discussions to advance Phase III development.

• XadagoⓇ/safinamide continues global commercialization, with US patent settlements securing exclusivity until at least December 2027 and SPCs approved in most EU territories.

• Initiated structured process to secure a value-creating transaction for evenamide, with several partnership or M&A offers under negotiation.

• Strengthened Board with the addition of a Non-Executive Director with significant transaction expertise.

Financial highlights

• Net loss for H1 2024 was EUR 9.6 million, compared to EUR 7.0 million in H1 2023; loss per share widened to EUR 0.51 from EUR 0.39.

• Cash used in operating activities increased to EUR 8.8 million from EUR 5.6 million year-over-year.

• Royalties from Zambon rose to EUR 3.4 million from EUR 3.2 million in H1 2023; total license income/royalties/other income was EUR 3.4 million, down from EUR 5.5 million in H1 2023 due to prior one-time payments.

• R&D expenses increased to EUR 6.5 million from EUR 5.7 million year-over-year.

• Cash and other current financial assets totaled EUR 12.2 million at June 30, 2024.

Outlook and guidance

• Expects to enter a value-creating transaction for evenamide in the coming months, enabling Phase III clinical development.

• Phase III trial for evenamide in TRS patients planned to start in H1 2025, with regulatory approvals in place for study design.

• Financial resources are expected to fund planned development programs and operations well into 2025.

• Continues to assess opportunities to expand the CNS pipeline.