Minerva Neurosciences (NERV) 12th Annual Cantor Fitzgerald Global Healthcare Conference summary

Company overview and focus

• Focused on addressing unmet medical needs in psychiatry, especially negative symptoms of schizophrenia.

• Successfully co-developed seltorexant with Johnson & Johnson; lead molecule is roluperidone.

• Negative symptoms, such as avolition and anhedonia, are early and core features of schizophrenia.

• Negative symptoms affect nearly all patients with schizophrenia at some point.

Disease insights and treatment landscape

• Negative symptoms often precede positive symptoms and are linked to functional impairment.

• Antipsychotics can worsen secondary negative symptoms by blocking dopamine.

• Removing antipsychotics can improve secondary, but not primary, negative symptoms.

• Many patients prefer to discontinue antipsychotics after extended use.

Roluperidone mechanism and clinical development

• Roluperidone targets primary negative symptoms via 5-HT2A antagonism and sigma activity.

• The drug stabilizes positive symptoms, improves sleep, and may enhance cognition.

• Two major studies (phase II-A and phase III) showed significant efficacy at 64mg, but not at 32mg.

• Anomalous data from one site in phase III was excluded after pre-specified review.