Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Doubt exists about the ability to continue as a going concern, requiring additional funding.
  • U.S. federal and state net operating loss carryforwards increased from $65 million to $86 million.
  • Added a new clinical trial for CAN-2409 in pancreatic cancer with up to 54 patients.
  • Seeking fast track designation for CAN-3110 and future product candidates, with no assurance of FDA approval.
  • Issued 109,485 shares of common stock under ATM Program, generating $0.2 million in net proceeds.
  • Enrollment paused in a randomized phase 2 clinical trial for pancreatic cancer, presented initial data.
  • Phase 3 clinical trial for CAN-2409 in prostate cancer fully enrolled with 711 patients.
  • FDA granted fast track designation for CAN-2409 plus valacyclovir in NSCLC to improve survival.
  • Potential delisting from Nasdaq due to stock price volatility below $1.00 per share.
  • Reported prolonged survival with CAN-2409 in pancreatic cancer, showing 71.4% survival rate.
  • Loss of CFO Jason A. Amello, replaced by Charles Schoch, may impact financial operations.
  • Identified material weaknesses in internal controls over financial reporting, with potential future weaknesses.
  • Organizational restructuring led to a significant reduction in the workforce from 76 to 42 employees.
  • Positive interim overall survival data for CAN-2409 in pancreatic cancer presented in Q4 2023.
  • Total outstanding shares of common stock increased from 28,919,347 to 29,810,468.
  • Doubt regarding the company's ability to continue as a going concern due to financial challenges.
  • Ongoing investigator-sponsored Phase 1/1b trial with CAN-3110 achieved 11.8 months mOS.
  • Entered into a loan agreement with Silicon Valley Bank, with a balance of $5 million.
  • CAN-3110 showed nearly doubling of expected mOS in recurrent HGG after a single injection.
  • Agreement with the FDA on the design and size of a pivotal phase 3 clinical trial for CAN-2409.
  • CAN-2409 Phase 2 trial in pancreatic cancer paused for new enrollment, data expected in Q2 2024.

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=1841387&owner=exclude

Click here to download the PDF

This content requires a 'Free' membership to view. Please create one here.
This content requires a 'Free' membership to view. Please create one here.