Risk Factors Update Summary
- The cost to manufacture product candidates is higher due to complexities, potentially impacting profitability.
- Potential adverse impacts from public health crises on clinical trials, including enrollment delays.
- Need for additional CMOs to produce clinical supply for late-phase trials at necessary scale.
- Sales Agreement with Cowen and Company for up to $100.0 million of common stock.
- Addition of new product candidates, including DSG3 / 1 - CAART and PLA2R - CAART, with effective dates in March 2023, May 2023, September 2023, and November 2023. This expansion may require significant additional financing for clinical trials and commercialization.
- Potential delays in approval processes due to security breaches or unauthorized access to sensitive data.
- Expiration of net operating loss carryforwards, with federal NOLs of $121.6 million expiring in 2037.
- Increase in full-time employees from 58 to 101, indicating a 43% growth in the workforce, which may impact operating expenses and productivity.
- Transition to dedicated suite for GMP manufacturing for CABA - 201 and MuSK - CAART programs with an initial term of 18 months, indicating a strategic shift in manufacturing operations.
- Increased control by major stockholders owning 39% of common stock, potentially influencing decisions.
- Accumulated deficit increased from $165 million to $233 million as of December 31, 2023, reflecting continued losses and potential financial challenges.
- Implementation of a preconditioning regimen in the DesCAARTesTM trial, including IVIg, cyclophosphamide, and fludarabine, may impact the assessment of early efficacy and delay characterization of CABA - 201 independent of the effects of the regimen.
- Planned increase in the share reserve under the 2019 Plan by 3,000,000 shares, subject to adjustment, to provide equity incentives, indicating a potential dilution of ownership for existing shareholders.
- Potential impact of geopolitical tensions with China on manufacturing partners, such as WuXi, due to executive orders and legislative proposals, highlighting risks associated with reliance on foreign vendors.
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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