Risk Factors Update Summary
- Decision for the EU - U.S. Data Privacy Framework extended to cover UK transfers.
- Completion of enrollment in Phase 2b portion and first patient in Phase 3 portion of AV-101 trial.
- Introduction of the UK Bill may alter UK and EEA data protection regime similarities.
- Increase in net losses from $23 million to $51 million for the year ended December 31, 2022.
- Potential dilution due to additional sales of common stock under the ATM Equity OfferingSM.
- Divergence between EU GDPR and UK GDPR could create additional regulatory challenges.
- Accumulated deficit increased from $87 million to $163 million as of December 31, 2023.
- Sale of shares under the Sales Agreement generated $44.3 million, with $30 million remaining.
- Cash and cash equivalents decreased from $129 million to $122 million as of December 31, 2023.
- Expected cash availability to fund operations extended from the second half of 2025 to 2026.
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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