Newron Pharmaceuticals (NWRN) H1 2025 earnings summary

Executive summary

• Achieved regulatory approval for pivotal Phase III ENIGMA-TRS program for evenamide as add-on therapy in treatment-resistant schizophrenia (TRS), with patient enrollment for ENIGMA-TRS 1 initiated in August 2025.

• Secured licensing agreements for evenamide with Myung In Pharm (South Korea) and EA Pharma (Japan and Asia), resulting in significant upfront and milestone payments.

• Published positive clinical and preclinical data on evenamide, reinforcing its potential as a transformative therapy for TRS and poorly responding schizophrenia patients.

• Leadership transition with Dr. Chris Martin elected as Chairman in April 2025, succeeding Dr. Ulrich Köstlin.

Financial highlights

• Revenue for H1 2025 was EUR 11.9 million, up from EUR 3.4 million in H1 2024, driven by licensing income and increased royalties.

• Net loss narrowed significantly to EUR 0.07 million from EUR 9.6 million in H1 2024; loss per share EUR 0.00 versus EUR 0.51.

• Cash and other current financial assets totaled EUR 43.2 million as of June 30, 2025, compared to EUR 9.8 million at year-end 2024.

• Operating activities generated EUR 33.4 million in cash, versus an outflow of EUR 8.8 million in H1 2024.

• R&D and G&A expenses decreased to EUR 6.1 million and EUR 4.4 million, respectively.

Outlook and guidance

• Focus remains on advancing the ENIGMA-TRS 1 and 2 Phase III studies for evenamide, with 12-week results from ENIGMA-TRS 1 expected in Q4 2026.

• Actively pursuing additional global partnerships and licensing opportunities for evenamide and expanding IP protection.

• Current liquidity expected to fund operations and development programs well towards the end of 2026.