Newron Secures Up to €38 Million for Phase III Evenamide Program in Schizophrenia

Newron Pharmaceuticals has secured up to €38 million in gross proceeds through an agreement with a group of existing and new shareholders from Europe and Asia, strengthening its financial position as it advances the Phase III ENIGMA-TRS program for evenamide in treatment-resistant schizophrenia.

The financing is structured in three tranches tied to the progress and outcome of the company's pivotal ENIGMA-TRS studies. An initial tranche of up to €15 million will be raised through the subscription of up to 779,624 newly issued shares at a price of €19.24 per share. A second tranche of €11 million will be subscribed as the ENIGMA-TRS 1 and 2 studies progress toward their 12-week results, expected in the fourth quarter of this year and no later than November 30, 2026, with pricing determined by an agreed formula. A final tranche of €12 million will be subscribed upon disclosure of positive results from the pivotal studies, also priced according to a predefined formula.

The share subscriptions are governed by the capital increase authorized by shareholders in 2018 and approved and empowered by the company's board in 2025. The initial newly issued shares are expected to be listed and traded on the SIX Swiss Exchange under the same ISIN as existing shares in the coming days following settlement. The shares are also expected to be listed on the Primärmarkt of the Düsseldorf Stock Exchange and traded on the Frankfurt Stock Exchange's Xetra platform.

Proceeds from the financing are expected to fund the global ENIGMA-TRS Phase III program and extend the company's cash runway beyond the anticipated 12-week pivotal data readouts, supporting continued development of evenamide as a potential first add-on therapy for patients with treatment-resistant schizophrenia.

The company's Chief Financial Officer stated that the investment by this group of existing and new shareholders is further validation of the development strategy for evenamide as the potential first add-on therapy in schizophrenia and as a new treatment option for the vast majority of patients who are poorly responding or resistant to available treatment options. The financing is expected to extend operational runway well beyond the upcoming 12-week results from the ENIGMA-TRS 1 and 2 pivotal studies and support continued execution of the Phase III development program.

The ENIGMA-TRS Phase III program consists of two pivotal trials. ENIGMA-TRS 1, initiated in August 2025, is a one-year, international, double-blind, placebo-controlled study enrolling at least 600 patients to evaluate evenamide 15 mg and 30 mg twice daily as an add-on therapy to current antipsychotics, including clozapine. ENIGMA-TRS 2, initiated in December 2025, is a 12-week, international, randomized, double-blind, placebo-controlled trial evaluating evenamide 15 mg twice daily as an add-on therapy in at least 400 patients with treatment-resistant schizophrenia.

Evenamide is an orally available new chemical entity with a mechanism of action distinct from currently marketed antipsychotics. It selectively blocks voltage-gated sodium channels and modulates glutamate release without affecting basal glutamate levels. It acts by selectively blocking voltage-gated sodium channels and exhibits no biological activity at more than 130 other central nervous system targets. It normalizes glutamate release induced by aberrant sodium channel activity, without affecting basal glutamate levels, due to inhibition of voltage-gated sodium channels. Preclinical and clinical data suggest potential synergistic effects when combined with existing antipsychotics, including clozapine, with benefits that may persist beyond drug degradation.

Treatment-resistant schizophrenia is defined as inadequate symptom relief despite treatment with therapeutic doses of two antipsychotics from different chemical classes for an adequate period. An estimated 15% of patients are resistant from illness onset, and up to one-third to half of all patients with schizophrenia may develop treatment resistance over time. Emerging evidence points to abnormalities in glutamate neurotransmission in these patients, highlighting the need for novel therapeutic approaches beyond dopamine receptor targeting.

Newron, headquartered near Milan, focuses on therapies for diseases of the central and peripheral nervous system. In addition to evenamide, the company markets Xadago/safinamide for Parkinson's disease through global partners.