Newron Pharmaceuticals (NWRN) H1 2026 earnings summary

Executive summary

• Advanced pivotal Phase III ENIGMA-TRS program for evenamide in treatment-resistant schizophrenia, with TRS-1 trial screening completed for 996 patients and target enrollment of 600 expected by mid-October 2026; TRS-2 US enrollment to resume after FDA discussions.

• Strengthened IP portfolio with a new European patent for evenamide, extending exclusivity to 2044, and initiated a Phase III trial in Japan with EA Pharma.

• Secured up to EUR 38 million in new equity financing, with EUR 20.5 million subscribed to date, and extended EIB loan maturity to June 2028, improving financial runway.

• Net loss increased to EUR 16.4 million in H1 2026, mainly due to higher R&D expenses and lower milestone revenues.

Financial highlights

• H1 2026 revenue was EUR 3.2 million, down from EUR 11.9 million in H1 2025, reflecting lower milestone and upfront payments.

• R&D expenses rose to EUR 14.6 million (H1 2025: EUR 6.1 million) due to expanded clinical activities.

• G&A expenses increased to EUR 5.2 million (H1 2025: EUR 4.4 million), partly from new stock appreciation rights.

• Cash and current financial assets at June 30, 2026, totaled EUR 32.9 million (Dec 31, 2025: EUR 28.9 million); post-period, cash increased by about EUR 11 million from milestone and financing tranches.

• Operating activities used EUR 10.8 million in cash, compared to generating EUR 33.4 million in H1 2025.

Outlook and guidance

• Sufficient cash resources to fund operations through most of 2027, including after key clinical readouts.

• 12-week results from ENIGMA-TRS 1 expected in Q1 2027; TRS-2 enrollment in the US anticipated to resume soon.

• Additional financing and out-licensing opportunities actively pursued to support medium-term liquidity.

• Focus remains on executing the ENIGMA-TRS Phase III program and exploring further development and commercial opportunities for evenamide.