Risk Factors Update Summary
- Net loss decreased from $570.3 million in 2022 to $408.2 million in 2023.
- Cash, cash equivalents, and marketable securities decreased from $465 million to $381 million.
- Phase 2/3 studies initiated in epilepsy and bipolar disorders, with a Phase 2 study in MDD.
- Phase 2/3 clinical trial initiated for BHV-8000 in Parkinson's Disease.
- Further analysis revealed consistent treatment effects of troriluzole in SCA3.
- FDA declined to review the NDA application for troriluzole due to unmet primary endpoint.
- Loss of "smaller reporting company" and "emerging growth company" statuses, becoming a large accelerated filer.
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.
To view the full company filings, click on the following link to be taken to the SEC EDGAR database landing page for the company: https://www.sec.gov/edgar/browse/?CIK=1935979&owner=exclude
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