Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Added details on royalty payments on net sales of products developed from collaboration with Amgen.
  • Lease expiration extended from October 2024 to October 2029, impacting long-term facility commitments.
  • Business now depends on proprietary platform success. Limited operating history poses evaluation challenges.
  • TSC-204 changed to TSC-203-A0201 for targeting melanoma associated antigen 1.
  • Limited experience in clinical trials and manufacturing poses challenges in product development.
  • Approximately 100 novel antigens increased to approximately 200 as targets for tumor infiltrating T cells.
  • Manufacturing enhancements, including CD8α/β and DN-TGFβRII, aim to improve TCR-T therapy responses.
  • Added manufacturing capacity at Waltham, Massachusetts, with potential $70 million investment.
  • Expanded target discovery efforts into T-cell mediated autoimmune disorders from diseases.
  • Two initial TCR-T product candidates increased to six for IND applications.
  • TSC-200 series changed to TSC-20X for TCR-T candidates in clinical development.
  • The threshold for an affirmative vote of holders increased to at least 66% of the voting power.
  • The number of full-time employees increased from 137 to 154, and part-time employees decreased from 1 to 0.
  • Increase in full-time employees from 137 to 154 and part-time employees from 1 to 0.
  • Risks related to adverse financial industry events could impact business operations and financial condition.
  • Revenue solely from product sales. Failure to raise capital may delay product development.
  • Initial safety data expected in first half of 2024, with multiplex therapy data in 2025.
  • Federal research and development tax credit carryforwards increased from $6 million to $11 million.
  • Net losses increased significantly from $26 million in 2020 to $89 million in 2023.
  • Federal net operating loss carryforwards decreased from $86 million to $84 million.
  • Enhanced TCR-T therapy development by advancing seven IND applications for solid tumor programs.
  • Ownership by executive officers, directors, and entities increased to approximately 32% of outstanding voting stock and 38% of outstanding common stock.
  • Rising inflation rates may increase operating costs, reduce liquidity, and impact credit access.
  • Expansion of ImmunoBank to include diverse TCRs for solid tumors aims to overcome resistance mechanisms.
  • FDA cleared IND application for T-Plex, serving as primary IND application for solid tumor program.
  • Global economic uncertainty may impact liquidity and growth opportunities, affecting market competitiveness.
  • Enrolling patients in screening protocol moved from middle to first quarter of 2023.
  • Expenses for research and development in the U.S. will be capitalized and amortized post-2021.
  • Increased inflation may affect operating costs, liquidity, and access to debt and equity capital.

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=1783328&owner=exclude

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