Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • The company may not pay dividends in the foreseeable future to finance operations.
  • Expansion of risk related to patent challenges and infringement, highlighting potential limitations and challenges. This change might result in increased legal costs and potential loss of exclusivity.
  • Added potential liabilities under environmental laws for hazardous materials, which could exceed resources.
  • Identified material weakness in internal controls may impact completion of initial business combination due to insufficient funds.
  • Addition of details on the licensing agreement with NKMAX, including milestone fees ranging from $1.0 million to $5.0 million.
  • Lack of prior BLA submission to the FDA or similar authorities for SNK01 and SNK02 poses regulatory approval risks.
  • Addition of contractual obligations, policies, and other obligations related to data privacy and security.
  • Increased reliance on CROs for clinical trials, with potential regulatory violations leading to penalties.
  • Increased focus on the risks associated with patent protection in various jurisdictions, emphasizing the challenges of obtaining and enforcing patents globally.
  • A new 1% U.S. federal excise tax on certain repurchases of stock was imposed.
  • Increased operating losses with net losses of $83.0 million in 2023, up from $26.7 million in 2022.
  • Substantial doubt expressed about ability to continue as a going concern without additional capital.
  • Description of the challenges related to the shelf life and long-term storage of product candidates, impacting commercial supply and expenses.
  • Description of risks associated with manufacturing process deviations impacting product quality and supply disruptions.
  • Inclusion of stringent laws and regulations related to data privacy and security in various jurisdictions.
  • Loss of key personnel could negatively impact operations and profitability, requiring negotiation of agreements.
  • SNK01 Phase I trial results show generally good tolerability with only four Grade 2+ events.
  • Dependence on third parties for clinical trials may lead to delays, additional costs, and potential data rejection.
  • Disclosure of the potential impact of global supply chain disruptions on constructing commercial-scale manufacturing facilities.
  • Risks associated with third parties conducting clinical trials, including delays, data quality, and termination consequences.
  • Addition of risks related to cybersecurity threats, including ransomware attacks and supply chain vulnerabilities, impacting operations and data security.
  • Disclosure of potential delays and disruptions due to contamination, shortages of raw materials, or supplier failures in the manufacturing process.
  • Entered into a $5.0 million revolving line of credit agreement with East West Bank.
  • The company will incur increased costs as a public company, impacting financial resources.
  • Outstanding debts of approximately $19.9 million as of December 31, 2023, inclusive of various loans.
  • Risks associated with adverse events could lead to trial halts, delays, or regulatory approval denials.
  • Entered into an equity and business loan agreement for a multi-draw term loan financing up to $5 million.
  • Inclusion of risks related to macroeconomic conditions like inflation, interest rates, and supply chain constraints, affecting operational costs and financial stability.
  • Revolving line of credit with East West Bank requires maintaining a minimum cash balance of $15.0 million.
  • Substantial accrued and unpaid transaction expenses and operating expenses post-Business Combination.
  • Increased interest rate on the multi-draw term loan financing to 7.50% if the East West Bank Loan Agreement is no longer outstanding.
  • Highlighting the risks associated with acquisitions and strategic collaborations, including increased expenses, debt, and operational challenges.
  • Public perception of cell-based therapies may impact acceptance, demand, and enrollment in clinical trials.
  • Additional financing is actively being sought to meet ongoing capital requirements and liquidity needs.
  • Emphasis on the impact of changes in financial accounting standards on business practices and financial reporting, potentially affecting results of operations.
  • Uncertainty in identifying and developing product candidates may lead to missed opportunities and commercial value.
  • Added compliance requirements with anti-corruption laws and regulations, subject to penalties and liabilities.
  • Failure to secure additional liquidity may lead to bankruptcy filing or liquidation, impacting stockholders.
  • Introduction of risks related to data privacy and security obligations, emphasizing the potential consequences of security incidents and breaches on operations and reputation.
  • Seeking expedited regulatory designations may not guarantee faster development or approval processes.
  • Potential impact of healthcare reform initiatives and legislative proposals on business operations and 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=1845459&owner=exclude

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