Risk Factors Update Summary
- Increased risk of intellectual property breaches due to reliance on third parties for clinical trials.
- Received delisting notification from Nasdaq due to Bid Price under $1 for 30 consecutive days.
- The Company announced entering into a Giiant License Agreement for PALI-2108, its only actively developed asset.
- Need to maintain minimum bid price of $1 per share for continued listing on Nasdaq.
- Potential significant financial impact from system failures, cyber-attacks, and data breaches.
- The success of PALI-2108 and LB1148 depends on development, regulatory approval, and commercialization.
- Dilution risk for existing shareholders due to potential issuance of up to 270,729,106 additional common shares.
- Identified material weakness in internal control over financial reporting, requiring remediation.
- The Company may face challenges in enrolling patients in clinical trials, potentially delaying progress.
- Expressed substantial doubt about ability to continue as a going concern, requiring additional financing.
- The Company's ability to secure additional funding for operations and clinical trials is uncertain.
- The Company's success depends on the ability to maintain intellectual property rights and comply with regulatory requirements.
- Net losses incurred of $12.3 million in 2023 and $14.3 million in 2022, with ongoing losses.
- The Company's reliance on third parties for clinical trials and development may pose risks.
- Reliance on third-party contractors for clinical drug supplies, with no infrastructure for supply.
- Dependence on third-party manufacturers and suppliers for compliance with laws and regulations.
- Uncertainty exists regarding reimbursement levels and pricing policies, impacting commercialization success.
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=1357459&owner=exclude
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