Risk Factors Update Summary

• Net operating loss carryforwards increased from $43.2 million to $58.6 million and $66.3 million to $122.6 million.
• Investing in common stock involves a high degree of risk due to requiring substantial additional funding, $64.7 million to $154.75 million accumulated deficit.
• Approval may be granted for significantly more limited indications than sought, impacting distribution and use.
• Addition of chronic Chagas disease to the portfolio of product candidates increases the scope of treatment.
• Potential need to modify trial protocols for ongoing Phase 2/3 trial could lead to increased expenses.
• Pursuing the LPAD pathway for approval may result in increased costs and adverse effects on business.
• Need for substantial funding to meet financial needs and pursue objectives, risking delays or cessation of development programs.
• Delays in hiring, retaining, or deploying key personnel due to funding shortages could negatively impact business.
• Dependence on third parties for preclinical and clinical studies could result in delays or non-compliance.
• Patient enrollment challenges in trials of epetraborole due to NTM lung disease rarity may delay trials.
• Uncertainty regarding state conformity to tax legislation may impact business and financial condition.
• Voluntary pause in Phase 3 trial enrollment due to seasonal conditions may affect trial progress.
• Reliance on third parties for clinical trials and manufacturing may lead to delays or non-compliance.
• Seeking accelerated approval may not expedite the approval process as expected.
• Seeking additional orphan drug designations for product candidates may not be successful.
• Delays in enrollment for pivotal Phase 2/3 trials of epetraborole may impact meeting trial endpoints.
• Reliance on third parties for preclinical studies, clinical trials, and manufacturing may pose risks.
• Increased focus on cybersecurity risks, including potential breaches and financial, legal, and reputational harm.
• Identified material weaknesses in internal control over financial reporting may impact accurate reporting.
• Failure to obtain orphan drug market exclusivity could adversely affect business prospects.
• Changes in government regulations may lead to reduced demand for product candidates or pricing pressures.
• Limited experience in designing NTM clinical trials and conducting trials in the U.S. may pose challenges.
• Uncertainties in clinical trials and potential delays in enrollment could impact necessary regulatory approvals.
• Potential emergence of bacterial resistance to product candidates may affect market potential and revenue.