Newron Pharmaceuticals (NWRN) H.C. Wainwright 28th Annual Global Investment Conference summary

Strategic positioning and market opportunity

• Focus on developing novel CNS therapies, with a 26-year track record and a marketed Parkinson’s drug generating over $120 million in royalties.

• Schizophrenia targeted as a large unmet need, with over 25 million patients globally and more than half poorly responsive or treatment-resistant.

• Evenamide positioned as the first and only glutamate modulator for schizophrenia, addressing both positive and negative symptoms by targeting the hippocampus.

• Strong intellectual property protection extends to 2044, with recent patent grants in Europe and Hong Kong and pending approval in the U.S.

• Partnership with Eisai Group includes up to EUR 117 million in payments and double-digit royalties, with a risk-adjusted NPV exceeding EUR 100 million for just 7% of the global market.

Clinical development and trial results

• Two pivotal global phase III studies underway, with over 1,000 patients enrolled and first key results expected in Q1 2027.

• Phase II and III data show significant efficacy and safety, with no relapses or hospitalizations in a one-year study and minimal side effects.

• Evenamide demonstrated sustained and increasing efficacy over one year, with 50% of patients no longer meeting criteria for treatment resistance and 25% achieving remission.

• Statistically significant improvements observed in PANSS and CGI-S scores, outperforming standard of care and showing benefits as an add-on to clozapine and olanzapine.

• Regulatory agencies worldwide have approved the pivotal program, and positive results from either of the two studies could lead to drug approval.

Forward-looking statements and investment highlights

• First 12-week pivotal study readout expected in Q1 2027, with a second study reporting in Q2 2027.

• If either study is positive, approval is anticipated; both positive would ensure approval.

• No other glutamate modulators in clinical development for schizophrenia, positioning evenamide as a unique market entrant.

• Large commercial potential with more than half of schizophrenia patients underserved by current therapies.

• Sufficient funding in place to advance the program and proven expertise in bringing CNS drugs to market.