Sparks - Newron Pharmaceuticals

Newron Pharmaceuticals has announced an equity issuance of up to €38m with a group of existing and new shareholders from Europe and Asia. Proceeds will be used to support the company’s Phase III ENIGMA-TRS programme, assessing lead asset evenamide in treatment-resistant schizophrenia (TRS).

The agreement involves an initial subscription corresponding to gross proceeds of up to €15m (780k new shares issued at €19.24 per share). Alongside the progress of the ENIGMA-TRS 1 and 2 trials towards the 12-week results (expected in Q426), and no later than 30 November 2026, the group will subscribe to an additional number of newly issued shares for total proceeds of €11m (at a subscription price to be calculated based on an agreed formula). Finally, the group will subscribe to an additional number of newly issued shares for proceeds of €12m upon disclosure of the ENIGMA-TRS results (conditional to such results being positive and at a subscription price to be calculated based on an agreed formula).

By way of background, ENIGMA-TRS 1 is a 52-week, randomised, double-blinded, placebo-controlled Phase III trial. It is assessing the efficacy, safety and tolerability of evenamide at 15mg and 30mg twice-daily doses compared to placebo. It will involve c 600 patients across study centres in Europe, Asia, Latin America and Canada. The results at 12 weeks post-randomisation are expected to be announced in Q426. The trial will then continue in a double-blinded and placebo-controlled setting up to one year, providing additional data on the durability of the treatment. ENIGMA-TRS 2 has been designed as a 12-week, randomised, double-blinded, placebo-controlled Phase III trial, evaluating evenamide at a 15mg dose in c 400 patients, compared to placebo. This is an international study, undertaken at centres in the US and selected additional countries. The endpoint analysis will be conducted at 12 weeks. Top-line results for ENIGMA-TRS 2 are also anticipated in Q426, potentially representing a significant catalyst for investor attention.