Minerva Neurosciences, Inc. Q4 FY2022 earnings call

• Remy Luthringer discussed interactions with the FDA regarding roluperidone for negative symptoms in schizophrenia, including Type C and Type A meetings, NDA submission in August 2022, and receiving a Refuse to File letter in October 2022.
• Fred Ahlholm discussed financial performance, including cash positions, R&D and G&A expense changes, and net loss figures.

Cash, cash equivalents, and restricted cash as of December 31, 2022, were approximately $36.2 million compared to $60.9 million as of December 31, 2021. Research and development expense for the fourth quarter of 2022 was $3.2 million, a decrease of $15.5 million from the fourth quarter of 2021 ($18.7 million). For the year ended December 31, 2022, R&D expense was $14.6 million, a decrease of $17.4 million from 2021 ($32 million). General and administrative expense for the fourth quarter of 2022 was $1.9 million, a decrease of $0.7 million from the fourth quarter of 2021 ($2.6 million). For the year ended December 31, 2022, G&A expense was $10.6 million, a decrease of $2.7 million from 2021 ($13.3 million). Net loss for the fourth quarter of 2022 was $6.7 million, compared to a net loss of $21.3 million in the fourth quarter of 2021. For the year ended December 31, 2022, net loss was $32.1 million, compared to a net loss of $49.9 million in 2021.

• Anticipates further discussion with the FDA over the coming months regarding the status of the roluperidone NDA and development program.

• FDA concerns about applicability of Phase 2b data conducted in Europe to the U.S. population.
• Phase 3 study not meeting the primary endpoint.
• FDA seeking reassurance on identifying patients who don't need antipsychotics and evaluating patient stability.
• Concern that roluperidone may be used differently than intended and not shown to not interfere with safety/efficacy of antipsychotic medications.

Q: Can you remind us the latest and greatest outstanding issues the FDA has following the recent Type A meeting with the NDA?

A: The main concerns are applicability of Phase 2b study results to U.S. patients and Phase 3 study issues with Hochberg correction. Ongoing dialogue with FDA to provide data on comparability and function improvement.

Q: Any thoughts on the timing of the resolution or outcome of the NDA?

A: Dialogue is ongoing, but timing can't be specified; hope for shortest timeline with in-depth review needed.

Q: Who at the FDA has been overseeing the NDA application? Does Billy Dunn's departure change calculus?

A: Main dialogue with psychotic division; Dr. Dunn was involved, but replacement is knowledgeable and open to innovation, so no major change.

Q: When envisioning the path forward for roluperidone, would an additional study be needed?

A: FDA never asked for additional study; current data package is being reviewed, and post-approval studies are open, but existing data is being assessed for in-depth review.