Newron Pharmaceuticals (NWRN) 3rd Annual Guggenheim Healthcare Innovation Conference summary

Pipeline and near-term priorities

• Evenamide is in two pivotal add-on studies for treatment-resistant schizophrenia (TRS), an unmet need affecting more than one-third of patients with schizophrenia.

• ENIGMA-TRS 1 enrolled 618 patients in a one-year, double-blind, placebo-controlled study; 12-week results are expected in Q1 2027, 26-week results in Q2, and 52-week results later.

• ENIGMA-TRS 2 is planned for 400 patients; more than 100 had entered screening and about 50 were randomized. Twelve-week results are expected in Q3 2027.

• Management expects 2027 to bring at least three study readouts, potential ex-U.S. partnerships, and a possible NASDAQ uplisting.

Study design and regulatory plans

• ENIGMA-TRS 1 uses strict TRRIP criteria, investigator qualification, 42-day medication-compliance screening, and independent patient review; patients receive 15 mg, 30 mg, or standard of care as add-on therapy.

• The Q1 2027 ENIGMA-TRS 1 disclosure is expected to be limited to whether 30 mg showed statistically significant benefit and was safe and well tolerated; full 26-week data are planned for Q2.

• The 26-week results are intended to support rolling NDA submissions in the U.S. and Europe; the 52-week study continues to assess longer-term efficacy and pharmacoeconomic value.

• Management described both pivotal studies as powered for 95% probability, with 200 patients per arm; ENIGMA-TRS 1 has three arms and ENIGMA-TRS 2 has two.

FDA hold and safety discussions

• In April 2026, the FDA placed ENIGMA-TRS 2 on hold at U.S. sites after a death in Argentina; ENIGMA-TRS 1 was unaffected, and other participating countries continued the study.

• The FDA’s review raised questions about possible Brugada syndrome or other channelopathies; management said it is discussing genetic screening and potential U.S. enrollment criteria with the agency.

• If U.S. participation cannot proceed, management plans to accelerate ENIGMA-TRS 2 ex-U.S.; it also outlined a pre-NDA meeting and possible advisory committee as steps toward U.S. approval.