Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • The FDA announced draft guidance on "Clinical Trial Considerations to Support Accelerated Approval of Oncology Therapeutics" in March 2023.
  • Reported net losses decreased from $120.7 million to $73.8 million in 2022 and 2023.
  • The company may be unable to complete future strategic acquisitions, impacting business and financial condition.
  • The UK Adequacy Decision may expire in June 2025, affecting cross-border data flows and compliance costs.
  • Accumulated deficit increased from $212 million to $286 million.
  • Cash, cash equivalents, and short-term investments are expected to be sufficient into the second half of 2026.
  • FDA granted Orphan Drug Designation for PYX-201 in pancreatic cancer and PYX-107 in soft tissue carcinoma, esophageal, and GEJ cancers.
  • The Inflation Reduction Act allows Medicare to establish a "maximum fair price" for pharmaceutical products.
  • Confirmatory post-marketing trials must be completed pursuant to FDORA enacted in 2022.
  • New EU SCCs and UK GDPR impose onerous obligations on transfers of personal data.
  • Cash decreased from approximately $179.3 million to $119.3 million as of December 31, 2023.
  • Completed Private Placement resulted in gross proceeds of $50 million.
  • Recent healthcare reform efforts may significantly impact profitability for patented medicines.
  • Net proceeds of $10.6 million were obtained from additional shares under the ATM offering program.

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=1782223&owner=exclude

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