Minerva Neurosciences, Inc. Q3 FY2022 earnings call

• Submitted NDA for roluperidone to treat negative symptoms in schizophrenia on August 17, 2022, with data from Phase 2b and Phase 3 studies.
• Received refusal to file letter from FDA in October, requested Type A meeting to discuss reasons, expected before end of 2022.
• Highlighted no approved drugs in US for negative symptoms of schizophrenia; roluperidone shown to improve overall functioning of patients.
• Financial update: Cash, cash equivalents, and restricted cash at $40.3M as of 9/30/2022; R&D expense decreased due to completion of Phase 3 trial open-label extension, offset by consulting fees for NDA submission; G&A expense decreased due to lower legal and insurance costs; net loss decreased in Q3 2022 vs 2021.

No distinct product segments were discussed; financials included R&D, G&A, and net loss details but no breakdown by product segments.

• Existing cash and cash equivalents expected to meet capital requirements for at least the next 12 months based on current operating plan.
• Awaiting outcome of Type A meeting with FDA to clarify NDA status and next steps for roluperidone.

• Forward-looking statements are subject to risks and uncertainties detailed in SEC filings, including factors that may cause actual results to differ from forward-looking statements.

Q: Despite the RTF that you received, can we infer at this juncture whether the FDA now does feel comfortable about any of the issues they previously outlined in your prior Type C meeting?

A: Yes, we need to have the Type A meeting and will report after to provide clarity.

Q: If you guys were required additional data before roluperidone could be approved, does partnership make more sense now?

A: Will clarify after the Type A meeting on next steps.

Q: Did the FDA cite anything specific in the refuse to file letter?

A: Yes, they gave specific reasons which will be discussed in the Type A meeting.

Q: Did the FDA truly propose this Type A meeting as a recommendation?

A: Yes, the FDA proposed a Type A meeting.

Q: Are you working on other assets in the pipeline?

A: There is an early stage pipeline, and progress is expected next year if roluperidone progresses.