Risk Factors Update Summary

• Seeking regulatory approval to market imetelstat in Europe may result in additional risks.
• Addition of new text regarding the IPR process under the AIA and challenges to patent validity.
• Added the need to receive regulatory approval for commercializing imetelstat in lower-risk MDS.
• The company specifies exclusive forums for various claims, including those related to fiduciary duties.
• Inclusion of the ability to challenge patents in certain jurisdictions like Europe, New Zealand, and Australia.
• Addition of information on the settlement of securities class action lawsuits and derivative lawsuits.
• Disclosure of risks related to the volatility of stock price, potential decline in value, and factors influencing market fluctuations.
• Failure to achieve continued compliance with government regulations could severely affect financial results.
• The Federal Forum Provision designates federal courts for Securities Act claims, limiting stockholder options.
• Mentioned the FDA urging to consider adding a third dosing arm to IMpactMF trial.
• Changes in tax laws could impact the company's financial condition, with potential material adverse effects.
• Potential delays in clinical trials due to manufacturing risks could further delay regulatory approvals.
• Disclosure of risks related to the potential loss of patent rights and challenges to patents through various procedures.
• Inclusion of risks related to cybersecurity, data privacy, and potential security incidents.
• Highlighted the importance of establishing sales, marketing, and distribution capabilities for potential commercialization.
• The complexity of manufacturing imetelstat may lead to increased costs affecting financial results.
• Expansion on the risks related to intellectual property rights, patent disputes, and potential adverse outcomes.
• Discussed the potential negative effect of the Inflation Reduction Act on imetelstat pricing.
• New tax laws may affect domestic and foreign sales, earnings, and tax treatment, impacting operations.
• Noted the significance of maintaining orphan drug designation status for regulatory exclusivity.
• The need for additional financing and potential delays in clinical trials could impact operations.
• Changes in corporate tax rates or future tax reform could significantly impact deferred tax assets.
• The company's ability to use net operating loss carryforwards may be limited, affecting future tax liabilities.
• Risks related to intellectual property rights and patent challenges may affect future commercialization.
• Emphasized the need for effective training of sales personnel for commercializing imetelstat.
• Ownership changes could limit the company's ability to use pre-change tax attributes, impacting financial position.
• Uncertainty in the regulatory framework and legislation may delay marketing authorization and commercialization.
• Mentioned the variability in coverage and reimbursement for drug products among different payors.