Minerva Neurosciences, Inc. Q1 FY2021 earnings call

• Remy Luthringer discussed the open label extension of the Phase 3 study for roluperidone, highlighting long-term safety and continuous improvement of negative symptoms over time.
• Geoff Race mentioned the $60 million cash upfront from Royalty Pharma for seltorexant royalty, potential for up to $95 million in additional milestone payments, and that the company's cash is sufficient for at least 12 months.
• Discussed the significance of the open label extension data for roluperidone in treating negative symptoms of schizophrenia, including the unique continuous improvement over time observed.

Cash, cash equivalents, and restricted cash at March 31, 2021 were approximately $80.2 million compared to $25.5 million as of December 31, 2020. Research and development expenses were $3.3 million for the 3 months ended March 31, 2021, a decrease of approximately $4.8 million from $8.1 million in 2020. G&A expenses were $4.2 million for both the three months ended March 31, 2021 and 2020. Net loss was $8.8 million for the first quarter of 2021 compared to a net loss of $12.2 million in 2020.

• The company's existing cash and cash equivalents are expected to meet anticipated capital requirements for at least the next 12 months.
• Potential for up to $95 million in additional payments from Royalty Pharma contingent on the achievement of certain clinical, regulatory, and commercialization milestones for seltorexant.

• Uncertainty in clinical trial outcomes and regulatory approvals for seltorexant.
• Dependence on Royalty Pharma milestones for additional funding.
• Potential changes in operating assumptions that could affect cash sufficiency.

Q: What magnitude and progression of improvement in negative symptoms?

A: Improvement in negative symptoms is continuous over time, unique, with initial fast improvement then flattening, but in this study, continuous improvement over time is unique.

Q: Trigger for next FDA interaction?

A: Completion of bioequivalence study to finalize briefing book for next FDA discussion.

Q: Role of clinical trial environment and need for placebo-controlled study?

A: Study design shows continuous improvement, pharmacology supports positive symptom improvement, need for phase 4 studies.

Q: Performance of patients who switched from placebo to active vs those on active all along?

A: Patients who switched showed improvement in negative symptoms and functioning, similar to those on active all along.

Q: Dosing considerations, 32 mg vs 64 mg?

A: Both doses helpful, 64 mg better for functional improvement, 32 mg considered for pediatric studies.

Q: Relapse rate and comparison to literature?

A: Relapse rate in study is impressive, different patient population than literature examples.

Q: Bioequivalence study and seltorexant milestones?

A: Bioequivalence study aims for non-inferiority, seltorexant milestones include clinical, regulatory, sales.