Risk Factors Update Summary

• The company may face challenges in maintaining favorable pricing and reimbursement status in EU Member States, impacting revenue.
• Clinical trials have been put on clinical holds by the FDA, EMA, or similar authorities. For example, FDA placed holds on atuzaginstat and EryDex.
• Enhanced security measures to detect and mitigate vulnerabilities in internal systems.
• The company may incur up to $485.0 million in additional payments related to the EryDel Acquisition.
• Implemented Rights Agreement until April 5, 2024, discouraging change of control without board consent.
• The company's drug candidates may be negatively affected by changes in EU laws governing authorization of medicinal products.
• Failure in early clinical trials may not predict later-stage results, as seen in the Phase 3 ATTeST study by EryDel.
• The company shifted operational focus towards EryDel, intending to initiate the Phase 3 NEAT trial.
• Reliance on third parties for manufacturing and supply may lead to delays and additional costs.
• The company's accumulated deficit increased from $288 million to $319 million as of December 31, 2023.
• Added potential consequences of security breaches, including regulatory actions, litigation, and revenue loss.
• Failure to comply with healthcare laws, including the FCPA, could result in reputational risk, penalties, fines, or imprisonment.
• Added uncertainty about insurance coverage adequacy for privacy and security liabilities.
• The company incurred a $0.8 million goodwill impairment charge in September 2022.
• The company's ability to sell products may be negatively impacted by failure to comply with medical device regulatory requirements.
• Increased risks from ransomware attacks, remote work, and reliance on third-party service providers.
• The company may face challenges in adapting to changes in patent laws, potentially leading to increased competition.
• The company's cash, cash equivalents, and investments decreased from $93.8 million to $75.1 million.
• Uncertainty about future income tax liability due to federal net operating loss utilization.
• Delisting from Nasdaq could adversely affect the liquidity of the company's common stock and market interest.
• The company's R&D tax credit rate decreased from 20% to 10% for eligible expenses.
• The company's ability to raise funds for clinical trials and research programs may be compromised by uncertainties associated with litigation.
• The company incurred a total tax credit of $2.0 million in 2021, $1.1 million in 2022, and $877,000 in 2023.