Risk Factors Update Summary
- Early in development efforts, with limited operating history. Accumulated deficit increased from $279 million to $403 million.
- Research, development, and commercialization activities may result in claims that we infringe patents.
- Expect current cash, cash equivalents, and investments to fund operations for at least the next 12 months.
- European patent applications will now be subject to the Unified Patent Court (UPC).
- Granted orphan drug designation for TN-201 and TN-401, each by the FDA and TN-201 by the EC.
- Government actions may limit patent applications and maintenance, impacting our business in various jurisdictions.
- Changes in tax law may increase tax burden. Tax Cuts and Jobs Act of 2017 requires capitalization of domestic R&D costs.
- Concentration of ownership by executives and directors increased from 45% to 57% in 2023.
- Potential impact of legislative, executive, and administrative actions on the pharmaceutical industry.
- Shelf registration statement allows issuance and sale of up to $75.0 million of common stock.
- Increased liability due to GDPR and other data privacy laws, with potential fines up to €20 million.
- Provisions in our certificate of incorporation and bylaws could discourage or delay business combinations.
- Vulnerability to cyber-attacks and security breaches, posing risks to data integrity and availability.
- Any provision in our certificate of incorporation, bylaws, or Delaware law affecting stockholder rights could harm our business.
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=1858848&owner=exclude
This content requires a 'Free' membership to view. Please create one here.
This content requires a 'Free' membership to view. Please create one here.