Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Lease term for Dunkirk Facility extended to 5 years, with 300 employees to be hired within 2.5 years.
  • Outstanding promissory notes increased by $610.0 million to $610.0 million principal amount.
  • Anticipate needing additional financing for operations and product development, with $735 million in related-party promissory notes outstanding.
  • Submitted BLA for Anktiva in combination with BCG for BCG-unresponsive NMIBC. PDUFA action date set for May 23, 2023. Resubmission completed, new PDUFA date April 23, 2024.
  • FDA issued a CRL for BLA filed in May 2022, resubmitted in October 2023.
  • Dilution risk increased as Dr. Soon-Shiong and affiliates now own 79% of common stock.
  • Received a CRL from the FDA for a lead product, potentially delaying approval and commercialization.
  • Lack resources to pursue development of in-licensed technologies. Need additional capital, may face unfavorable terms.
  • Debt and revenue interest liability could adversely affect cash flows and limit flexibility, with $200 million revenue interest liability.
  • Sales milestone CVR agreement added, potentially paying $304.0 million upon N-803 sales exceeding $1.0 billion.
  • Collaboration with Infinity and Oberland for Revenue Interest Payments based on net sales, up to 10%.
  • FDA accepted BLA resubmission for review, setting a new PDUFA action date of April 23, 2024.
  • Potential litigation risks from strategic alliances or collaborations, including disputes with Sorrento and Amyris.
  • Risks related to reliance on third parties for clinical trials and essential services, including potential delays.
  • Potential impact on FDA approval if issues raised in CRL are not successfully addressed.
  • Reliance on third parties for manufacturing and clinical trials, potential delays or disruptions.
  • Increased compliance costs and potential liability due to changes in data protection laws.
  • Ongoing regulatory requirements and obligations may result in significant additional expenses, impacting financial position.
  • Lawsuits against federal government regarding price negotiation provisions of the IRA.
  • Risks related to intellectual property, potential conflicts, and changes in patent laws affecting product value.
  • Limited experience conducting clinical trials, reliance on third parties for preclinical studies and clinical trials.
  • Cybersecurity risks, including data breaches, interruptions, and potential financial, legal, or reputational harm.
  • Uncertainty regarding future trade relations between the U.S. and other countries.
  • The company's ability to make scheduled payments on debt and revenue interest liability may impact financial condition.

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=1326110&owner=exclude

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