Newron Pharmaceuticals S.p.A.

Newron did not give a full revenue/EPS presentation on the call, but Roberto Galli said license income declined versus 2024 because 2024 included the Eisai upfront payment; reported licensing income for 2025 was EUR 8.6 million, with about 30% from Myung In and the remainder from EA Pharma milestones. He also said other income included EUR 1.9 million of R&D tax credit benefit, and financial results net decreased by about EUR 3 million mainly due to a EUR 2.5 million IFRS warrant fair-value revaluation with no cash impact. On liquidity and capitalization, he said shares outstanding were around 20.8 million at year-end 2025, with up to 1.6 million warrants/call options outstanding. Forward-looking, management said TRS 1 should complete enrollment by end-August, with results by year-end and a potential NDA filing around the first to second quarter of 2027; TRS 2 was described as a 12-week study that may read out around December or early January and would be included in the registration package. Stefan Weber also said the company has the cash to complete the ENIGMA-TRS studies through the 12-week readout and has reserves beyond that point.

Stefan Weber framed the past 15 months as a major validation period for evenamide, citing the EA Pharma deal, first pivotal study starts, peer-reviewed publications, and new patent progress. He emphasized that Newron is trying to build toward a much larger outcome over the next 12 to 15 months, with pivotal data, NDA preparation, and potentially a U.S. listing as future milestones. His tone was very optimistic, but he also made clear that an uplisting or IPO to NASDAQ is not something they can do immediately without the right results and share price.

Roberto Galli focused on funding, capital structure, and reported financial items. He said Newron ended 2025 with about 20.8 million shares outstanding, plus up to 1.6 million warrants/call options, and highlighted the new financing package, the EIB repayment delay to June 2028, and the resulting improved cash position. On the P&L, he pointed to EUR 8.6 million of licensing income, EUR 1.9 million of R&D tax credits, and a roughly EUR 3 million decline in financial results net, mainly from a EUR 2.5 million non-cash warrant revaluation under IFRS. He also clarified that the EUR 12 million contingent piece of the new financing was left out of cash-reach guidance because it depends on positive data, but could extend runway further if triggered.

Analysts pressed on how broadly evenamide might work beyond schizophrenia, and Ravi Anand cited bipolar disorder, treatment-resistant depression with psychotic features, and behavioral symptoms of dementia as possibilities. On combination therapy, he said clozapine is the obvious candidate, while olanzapine was particularly surprising in the data, and he said the company is checking plasma levels in Phase III to rule out pharmacokinetic explanations. Questions also covered the long-lasting biological effect despite short half-life and whether that could support a long-acting injectable; management said they would explore depot formulations after the NDA, potentially with formulation partners. On timing, management said TRS 1 is very likely to read out this year, TRS 2 is borderline between December and early January, and the two announcements would be separate but included in the filing package.