Minerva Neurosciences (NERV) The Citizens Life Sciences Conference 2026 summary

Unmet medical need and disease overview

• Schizophrenia's negative symptoms remain untreated in the U.S., with no approved therapies addressing this aspect.

• Negative symptoms, such as loss of motivation and pleasure, precede positive symptoms and drive long-term functional impairment.

• Antipsychotics treat positive symptoms but can worsen negative symptoms, compounding patient disability.

• Improving negative symptoms is essential for restoring daily functioning and quality of life.

Roluperidone mechanism and differentiation

• Roluperidone avoids dopamine blockade, targeting 5-HT2A and sigma pathways to stabilize positive symptoms and improve negative symptoms.

• 5-HT2A antagonism helps maintain positive symptom stability and normalizes circadian rhythms.

• Sigma pathway modulation is linked to improvements in negative symptoms and neuroplasticity.

• The drug increases nerve growth factors (BDNF, GDNF), potentially restoring neurodevelopmental deficits.

Clinical data and trial outcomes

• Phase II and III studies showed significant improvements in negative symptoms and daily functioning with roluperidone monotherapy.

• Functional gains were observed, including real-world examples of improved patient engagement and independence.

• Consistent efficacy was demonstrated at the 64 mg dose across studies, despite placebo effects.

• Long-term data indicate sustained improvement in symptoms and functioning over one year.