Strategic Partnership and Initial Funding Secured
December 2024 licensing deal with EA (Eisai Group) validated evenamide and generated EUR 48 million collected to advance Phase III. New funding agreement provides access up to EUR 38 million (EUR 15m already in bank, EUR 11m expected before year-end with no milestones attached, and EUR 12m conditional on positive pivotal results). European Investment Bank loan repayments delayed to no earlier than June 2028, improving near-term liquidity runway.
Pivotal Clinical Program Now Large and Global
Running three pivotal studies across >1,300 patients worldwide: ENIGMA-TRS1 (600-patient, 52-week double-blind placebo-controlled TRS study with 12-week primary readout), ENIGMA-TRS2 (U.S.-initiated pivotal study), plus partner Eisai's Phase III program. Management expects 12-week readouts within the year and enrollment completion milestones (TRS1 enrollment expected to complete by end of August).
Positive Clinical Efficacy Signals and Durable Effects
Phase III 8A (4-week, n=291) produced statistically significant efficacy: PANSS total p=0.006 and CGI-S p=0.037. Earlier 1-year add-on data in treatment-resistant schizophrenia showed large improvements (management described 'doubling/tripling' responder rates over 1 year and ~50% of patients no longer meeting treatment-resistant criteria, with reports of 6-month remission). Simulations project 12–14 point PANSS improvement at week 12 and 14–19 points by week 26.
Favorable Safety and Low Attrition
Evenamide exhibits a benign safety profile in trials: the most common AE was nasopharyngitis with incidence similar to placebo, and trials reported no clinically relevant extrapyramidal symptoms, weight gain, metabolic effects, sexual dysfunction, ECG, liver or kidney signal. Reported attrition rates <5%.
Strengthened IP Position with Potential Extended Exclusivity
European patent on crystalline forms of evenamide granted (filed earlier) and expected to be approved in other key territories; if granted in the U.S., this could extend market exclusivity to 2044 (~17 years post expected approval at end-2027). Existing COM in U.S. runs to 2035 and process patents to 2042; company actively pursuing accelerated U.S. prosecution.
Improved Market Perception and Institutional Interest
Three new U.S. analyst coverage additions (Wainwright, ROTH Capital, Lucid) plus additional European coverage; management cites liquidity having 'doubled or tripled' and daily trading between ~0.7%–1.0% of shares outstanding. Shares outstanding ~20.8 million; outstanding warrants/call options up to ~1.6 million.
Clear Commercial Opportunity and Indication Expansion Potential
Evenamide is positioned as the first glutamate-modulating add-on for schizophrenia with potential to address negative symptoms and cognition; management and CMO highlighted additional attractive indications (bipolar disorder, treatment-resistant depression with psychotic features, behavioral symptoms in dementia). Comparators/precedents (Karuna, Intra-Cellular) were cited to illustrate potential commercial upside.
Tax and Non-Operational Financial Benefits
R&D tax credit benefit of EUR 1.9 million booked in 2025; accumulated R&D tax benefits since 2025 total ~EUR 25 million, of which ~EUR 22 million have been used (~88% utilized).