Minerva Neurosciences, Inc. Q4 FY2020 earnings call

• In May 2020, top line results from the double-blind portion of the Phase 3 trial with roluperidone in negative symptoms of schizophrenia were announced, though the study didn't meet statistical significance, but promising signals emerged.
• In November 2020, a Type C meeting with the FDA occurred where the FDA cautioned an NDA submission based on then current data from Phase 2b and Phase 3 studies would be highly likely not to be filed; ongoing dialogue with the agency.
• In January 2021, received a $60 million cash payment from Royalty Pharma in connection with the acquisition of royalty interest in seltorexant. Existing cash and the $60 million payment are expected to meet capital requirements for at least the next 12 months.
• R&D expense decreased in Q4 2020 and for the year 2020 due to factors like an impairment charge in 2019 and completion of Phase 2b and Phase 3 trials.
• G&A expenses decreased in Q4 2020 and for the year 2020 primarily due to lower pre-commercial expenses offset by higher insurance costs.

Cash, cash equivalents, and restricted cash as of December 31, 2020 were approximately $25.5 million compared to $46 million as of December 31, 2019. Research and development expenses were $3.6 million and $28.5 million for the fourth quarters of 2020 and 2019 respectively. R&D expenses were $22 million and $58.1 million for the years ended December 31, 2020 and 2019 respectively. G&A Expenses were $3.7 million and $3.8 million for the fourth quarters of 2020 and 2019 respectively. G&A expenses were $17.3 million and $17.7 million for the years ended December 31, 2020 and 2019 respectively.

• The company's existing cash and cash equivalents, combined with the $60 million payment received in January 2021, are expected to meet anticipated capital requirements for at least the next 12 months based on current operating plan.
• Look forward to sharing data from the Phase 3 nine months open-label extension in the first half of 2021.

• Assumptions upon which the estimate of cash sufficiency is based are routinely evaluated and may be subject to change.
• The FDA review process for NDA submission is dynamic and uncertain, with potential challenges in getting the NDA accepted.

Q: Is there any data from the upcoming open-label extension analysis that could address pushback from the FDA in the recent Type C meeting?

A: The extension data will be encouraging as it will confirm sustained improvement in negative symptoms, functional improvement, positive symptom data, and relapse rates. We'll be able to check PANSS and PSP over the nine-month extension, having one-year data, and check positive symptoms and relapses.

Q: How many patients from the placebo arm of the double-blind trial rolled over into the open-label extension?

A: Approximately the same number from each treatment arm; the data will be released at a medical meeting.

Q: Thoughts on the modified ITT analyses and interaction with the FDA?

A: There are precedents in the neuroscience space for modified ITT analyses being accepted by the FDA; we're in ongoing dialogue with the FDA regarding this.

Q: Details on the bioequivalence study?

A: The bioequivalence study has 48 subjects, focusing on AUC vs Cmax, and uses PANSS negative scores as a pharmacodynamic marker.

Q: Interpretation of the FDA's Type C meeting and current status?

A: The open-label data wasn't available during the Type C meeting; current open-label data helps confirm the efficacy of roluperidone, and we're in continuous dialogue with the FDA.

Q: Thoughts on the 32 mg dose in the open-label extension?

A: 32 mg showed a pharmacological effect; extension data will inform next steps regarding the 32 mg dose.