
Financial Performance - The company reported an accumulated deficit of approximately 395.4 million as of December 31, 2024[76]. - For the three months ended March 31, 2025, the company recorded a net loss of 8.6 million for the same period in 2024, representing a reduction of approximately 56%[76]. - Net cash used in operating activities was approximately 6.1 million for the same period in 2024[107][109]. - The net loss for the three months ended March 31, 2025, was 8.6 million in the same period of 2024[108][109]. Expenses - Research and development expenses decreased to 4.2 million in the same period of 2024, a decrease of approximately 67%[90]. - General and administrative expenses remained constant at 158 thousand for the three months ended March 31, 2025, down from 17.4 million in cash, cash equivalents, and restricted cash, which is expected to meet operating commitments for the next 12 months[96]. - The company expects to finance cash needs through equity offerings, debt financings, and collaborations, which may dilute existing stockholders' interests[105]. - The company believes its existing cash and equivalents will be sufficient to meet cash commitments for at least the next 12 months[105]. - A $60 million payment from Royalty Pharma for the sale of royalty interests in seltorexant is recorded as a liability related to future royalties[104]. Regulatory and Operational Outlook - The FDA issued a Complete Response Letter (CRL) for the NDA of roluperidone on February 26, 2024, citing the need for additional studies to support its safety and effectiveness[75]. - The company anticipates continuing to incur net losses for the foreseeable future as it develops its product candidates and supports its operations as a public company[96]. Company Classification and Accounting Policies - The company is classified as a "smaller reporting company" and may take advantage of scaled disclosures under the Securities Exchange Act[114]. - Critical accounting policies include research and development costs, goodwill, and liabilities related to future royalties[112].