Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Identified substantial doubt about ability to continue as a going concern due to insufficient cash.
  • Potential fines under GDPR increased to up to 20 million Euros or 4% of total worldwide annual turnover.
  • Addition of "one or more" collaborations increases reliance on third parties for development and commercialization.
  • A 1-for-20 reverse stock split was effected on September 28, 2023, potentially affecting trading liquidity.
  • Net loss decreased from $56 million to $47 million for the year ended December 31, 2023.
  • Mention of ongoing litigation challenging FDA approvals impacting the development and commercialization of products.
  • President Biden signed an executive order implementing the EU-U.S. Data Privacy Framework.
  • Switzerland is in the process of approving an adequacy decision for data transfers to the U.S.
  • Accumulated deficit increased from $1.1 billion to $1.2 billion as of December 31, 2023.
  • Mention of "manufacturing delays" if third-party contractors prioritize other products over emavusertib.
  • Addition of potential delays in commencing clinical studies in the EU due to new regulations.
  • The EC adopted an adequacy decision on July 10, 2023, permitting U.S. companies to rely on the EU-U.S. Data Privacy Framework.
  • Privacy and data security laws in various countries may impact business activities and increase compliance costs.
  • Sales of Erivedge were first recorded in the U.S. during the fourth quarter of 2015.
  • Inclusion of "manufacturing delays" due to potential interruptions in the supply of raw materials.
  • Inclusion of risks associated with the delay in obtaining marketing approval in foreign jurisdictions.
  • Entered into a new sales agreement allowing the sale of up to $100.0 million of common stock.
  • Introduction of risks related to Brexit and the need for new marketing authorizations in the UK.
  • The UK and the EU have determined data transfers between them are compliant with the UK Data Protection Act and GDPR.
  • Estimated amount of the Put/Call Price decreased from $72.5 million to $56.9 million as of December 31, 2023.
  • Deprioritized and did not exercise the option to license CI-8993 after not reaching the maximum tolerated dose.

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=1108205&owner=exclude

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