Risk Factors Update Summary
- Intending to enter human studies of proprietary psilocybin formulation in 2024, with no assurance of study completion.
- IRA allows HHS to negotiate selling prices of certain drugs, with negotiated prices taking effect in 2026.
- Accumulated deficit increased from $462 million to $560 million by December 31, 2023.
- Potential Phase 3 clinical trials' success may impact demonstrating safety and efficacy of esmethadone and future product candidates.
- Cash, cash equivalents, and short-term investments decreased from $148.3 million to $96 million by December 31, 2023.
- Number of full-time employees increased from 14 to 16, impacting operations and recruitment.
- Federal, New York State NOL carryforwards decreased from approximately $118 million to $100 million.
Full Text Changes in Most Recent 10-K
Intended use: review the highlighted statements. These are additions to the risk factors disclosure in the most recent 10-K filing compared to the previous 10-K filing. Deleted and moved text is less important and is shown for context.
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