Company – Scrape Financial
Risk Factors Summary

Risk Factors Update Summary

  • Net cash used in investing activities decreased significantly from $144.0 million in 2022 to $5.0 million in 2023.
  • The company may need to secure additional funding to avoid delays or reduce research programs. This could dilute stock ownership and impact stock price.
  • Third-party payors may require additional studies or regulate prices, impacting research and development.UT:
  • Stock-based compensation modification decreased from $317,000 to $163,000, impacting remaining service period by approximately $98,000.
  • The company authorized the issuance of 65,000,000 shares of common stock and 2,500,000 shares of preferred stock, a change from the previous authorization.
  • The company's ability to protect intellectual property is crucial for commercialization success and may impact its ability to compete effectively.
  • Pricing pressures globally and in the U.S. may impact revenue. Expect continued focus on regulating pricing.
  • The company's ability to commercialize products heavily depends on obtaining and maintaining necessary regulatory approvals.
  • Sales of common stock in private placements and equity financing arrangements may impact market price.
  • The company's future success heavily relies on the successful development and commercialization of gedatolisib.
  • The Policy outlines recoupment of Erroneously Awarded Compensation, including pre-tax recoupment of excess amounts.
  • Net cash provided by financing activities increased from $120.3 million in 2022 to $64.9 million in 2023.
  • Restricted stock outstanding decreased from 3,273 to 1,958 shares at December 31, 2023.
  • The company issued pre-funded warrants to purchase 5,747,787 shares of common stock at an exercise price of $0.001 per share.
  • The company's success is highly uncertain and dependent on the successful completion of clinical trials and regulatory approvals.
  • The company faces significant competition in the biopharmaceutical industry, impacting its ability to compete effectively.
  • Calculation of Erroneously Awarded Compensation includes excess shares received and accrued earnings on notional amounts.
  • Increased compliance costs and legal risks due to evolving data privacy regulations and uncertainties.
  • Legislative changes may require manufacturers to engage in price transparency or limit drug price increases.
  • Financing activities in 2023 included net proceeds from a pre-funded warrants offering and ATM offering totaling $64.4 million.
  • Recoupment methods include canceling future incentives or requiring repayment by Executive Officers promptly.
  • Increased legal, accounting, and compliance expenses as a public company compared to a private company.
  • The success of CELsignia tests depends on attracting pharmaceutical partnerships and demonstrating advantages on a cost-competitive basis.
  • Privacy and security laws are rapidly evolving, impacting the collection and processing of personal data.
  • The company amended its Certificate of Incorporation to increase the authorized number of shares of common stock to 6,956,450 with an adjusted exercise price of $8.05 per share.
  • The Company believes utilization of third-party reports accurately reflects expenses incurred.
  • Unrecognized compensation cost related to stock options and restricted stock increased from $3,347,075 to $4,255,020 at December 31, 2024.
  • Changes in estimates may become more significant as the VIKTORIA-1 Phase 3 and CELC-G-201 Phase 1b/2 trials progress.
  • The Company's auditor changed from Boulay PLLP to Boulay LLP in March 2024.
  • Total stockholders' equity increased from $133.8 million in 2022 to $139.8 million in 2023.

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=1603454&owner=exclude

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