NERV

• Roluperidone Program: Received FDA confirmation of NDA filing on April 27, 2023, with PDUFA goal date of February 26, 2024, and no advisory committee planned. Discussed negative symptoms in schizophrenia, roluperidone's mechanism, and clinical trial details including Phase 2b and Phase 3 results. • Financials: Cash, cash equivalents, and restricted cash as of March 31, 2023, were ~$36.1 million. R&D expense decreased due to lower non-cash stock compensation costs and consultant fees related to the NDA. G&A expense decreased due to non-cash stock compensation. Non-cash interest expense increased due to amortization of the liability related to the sale of future royalties for seltorexant.

• Expect existing cash and cash equivalents to be sufficient to meet anticipated capital requirements for at least the next 12 months based on current operating plan. • Consideration of potential partnership for roluperidone launch, but no specific forward-looking revenue or sales guidance beyond general capital planning.

There are no distinct product segments detailed in the transcript. Financials provided include cash, cash equivalents, and restricted cash as of March 31, 2023, being approximately $36.1 million. Research and development expense for the three months ended March 31, 2023, was $2.7 million compared to $5 million in 2022, a decrease of $2.3 million. General and administrative expense was $2.7 million compared to $3 million in 2022, a decrease of $0.3 million. Net loss was approximately $7 million for the first quarter of 2023.

• Forward-looking statements are subject to risks and uncertainties detailed in SEC filings, including factors that may cause actual results to differ materially from forward-looking statements. These risks are more fully detailed in the company's quarterly report on Form 10-Q for the quarter ended March 31, 2023.

Q: What do you think exactly drove the FDA to grant this appeal in favor of you guys?

A: Hello. Good morning, Andrew. Remy speaking. So I think what happens is that when we went for this Formal Dispute Resolution Request, as you know, you have to provide with an additional briefing book and you have to detail why you think that your NDA is having all the information needed for a review, yes. And I think because we had the chance to have a face-to-face meeting and to have the attention of the people from the FDA attending the meeting, I think, they came to the same conclusion as we are coming, which is that this, how to say, data set we have in our NDA, it needs really an in-depth review, yes. And as you know, this is only possible when the FDA starts to really look to the data. It’s a long story short, no new data have been added, it was just a matter of re-explaining what is in the NDA and to have the attention from the person from the FDA Q: Can you remind us for seltorexant, what remaining economics you may be entitled to or might be eligible to receive?

A: I think this is for Geoff. Geoff Race: Yeah. Thanks for the question, Doug. So we have approximately $95 million left in terms of the milestones in the agreement that we signed with Royalty Pharma. There’s a $10 million milestone, which is dependent on the Phase 3 clinical study and then there’s approximately $60 million related to regulatory approval in various different geographies. Douglas Tsao: Okay. And are there -- and then the rest would be commercial -- related to commercial? Geoff Race: That’s correct.