Newron Pharmaceuticals (NWRN) H2 2025 earnings summary

Executive summary

• Achieved major licensing deals for evenamide in Japan/Asia and South Korea, generating nearly EUR 48 million in downpayments and milestones in 2025, and initiated pivotal Phase III ENIGMA-TRS clinical program for treatment-resistant schizophrenia with global enrollment underway.

• Evenamide demonstrated statistically significant efficacy and excellent tolerability in Phase II/III studies, with peer-reviewed publications and broad conference presentations highlighting its novel mechanism and efficacy for both positive and negative symptoms.

• Secured strong intellectual property protection, including a new European composition of matter patent extending exclusivity to 2044, with U.S. approval pending.

• Strengthened leadership with a new Chairman, new Board appointments, and proposed new independent directors for the AGM.

• Entered agreements for new share subscriptions and extended EIB loan maturity to June 2028, enhancing financial stability.

Financial highlights

• Booked EUR 48 million from licensing deals, with FY 2025 license income at EUR 8.6 million, down from EUR 44.5 million in 2024 due to the prior year’s large upfront payment.

• Royalties increased to EUR 7.8 million in 2025 from EUR 6.9 million in 2024.

• R&D expenses rose to EUR 15.1 million in 2025, up from EUR 13.6 million in 2024.

• Net loss of EUR 13.2 million in 2025 (EPS: -EUR 0.66), compared to a net profit of EUR 15.8 million in 2024 (EPS: EUR 0.85).

• Cash and financial assets at year-end 2025 totaled EUR 28.9 million, up from EUR 9.8 million at the start of the year.

Outlook and guidance

• Initial pivotal data readout from ENIGMA-TRS 1 expected in Q4 2026, supporting NDA submission in early 2027.

• Cash resources, including proceeds from new share issuance, expected to fund operations and development through 2027, with an additional EUR 12 million contingent on positive study results.

• Exploring additional indications for evenamide, including bipolar disorder, treatment-resistant depression with psychotic features, and behavioral symptoms of dementia.

• Preparing for potential NASDAQ uplisting and capital increase to support further development and market access.