Newron Pharmaceuticals has secured up to EUR 38 million in gross proceeds to support its Phase 3 evenamide programme in treatment-resistant schizophrenia, extending its cash runway beyond upcoming pivotal 12-week data from the ENIGMA-TRS studies.

The Milan and US-based company entered into an agreement with a group of existing and new shareholders from Europe and Asia for the subscription of newly issued shares in multiple tranches linked to clinical milestones.

The initial tranche will generate up to EUR 15 million through the subscription of up to 779,624 new shares at EUR 19.24 per share. Two further tranches, totalling EUR 23 million, are tied to the progress and results of the ENIGMA-TRS 1 and ENIGMA-TRS 2 Phase 3 trials. The second tranche of EUR 11 million is expected alongside advancement towards 12-week results, anticipated in Q4 2026 and no later than November 30, 2026. A final EUR 12 million tranche is conditional upon positive pivotal study results.

The financing is designed to support global execution of the ENIGMA-TRS Phase 3 programme and provide operational visibility through key data readouts.

Roberto Galli, cfo of Newron, said: “The investment by this group of existing and new shareholders is further validation of our 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. Importantly, this financing is expected to extend our operational runway well beyond the upcoming 12-week results from the ENIGMA-TRS 1 and 2 pivotal studies and support continued execution of our Phase III development program.”

Evenamide is being developed as an add-on therapy for patients with treatment-resistant schizophrenia, a population with limited options beyond clozapine. A substantial proportion of patients with schizophrenia show inadequate response to available antipsychotics, with estimates suggesting up to one-third to 50% may meet criteria for treatment resistance.

The ENIGMA-TRS Phase 3 programme consists of two pivotal studies. ENIGMA-TRS 1, initiated in August 2025, is a one-year, international, double-blind, placebo-controlled study enrolling at least 600 patients. It is evaluating evenamide 15 mg and 30 mg twice daily as add-on therapy to existing antipsychotics, including clozapine.

ENIGMA-TRS 2, initiated in December 2025, is a 12-week, randomised, double-blind, placebo-controlled Phase 3 study enrolling at least 400 patients. It is assessing evenamide 15 mg twice daily as an add-on to current antipsychotic treatment, including clozapine.

Evenamide is an orally available new chemical entity with a mechanism distinct from marketed antipsychotics. It selectively blocks voltage-gated sodium channels and modulates glutamate release without affecting basal glutamate levels. The programme is based on evidence suggesting that abnormalities in glutamate neurotransmission may contribute to treatment-resistant schizophrenia, which is not adequately addressed by dopamine-focused therapies.

If successful, evenamide could represent the first add-on therapy specifically targeting glutamatergic dysfunction in treatment-resistant schizophrenia, potentially expanding options for patients who do not respond to existing antipsychotic regimens.

The newly issued shares from the initial tranche are expected to be listed on the SIX Swiss Exchange and traded in Germany following settlement. The total number of shares ultimately issued will depend on the share price at the time of execution of the additional tranches.

With pivotal data expected later this year, the funding strengthens Newron’s balance sheet at a critical stage in late-stage development, positioning the company to deliver key Phase 3 results while maintaining flexibility for continued execution of its schizophrenia programme.