Risk Factors Update Summary

• Expanded product liability exposure now includes diagnostic tests and services, potentially leading to substantial liabilities.
• Added potential asset and business acquisitions, expenditures associated with the commercial launch of ENTADFI. This change might result in increased financial commitments.
• Legislation like the Inflation Reduction Act may impact marketing and profitability of ENTADFI. This could result in rebates owed to Medicare if prices are raised higher than inflation.
• The company faces increased uncertainties and costs due to the implementation of the AIA.
• Failure to maintain effective internal controls could impair financial reporting accuracy and lead to penalties.
• Recent U.S. Supreme Court rulings have created uncertainty around obtaining and enforcing patents.
• Working capital deficit increased from approximately $11.4 million to $18.1 million. This change highlights a worsening financial position.
• Increased employee count from 12 full-time and 11 subcontracted to 24 total employees.
• Net loss increased from $13.4 million to $37.4 million for the year ended December 31, 2023. This change indicates a significant negative financial trend.
• Identified material weaknesses in internal controls could result in adverse effects on the business.
• Approval of a combined finasteride-tadalafil capsule by Zydus Life Sciences may impact market competition.
• Shareholders may not benefit from recent acquisitions of ENTADFI and Proteomedix due to ownership dilution.
• Competition from other prostate cancer diagnostics and larger companies poses challenges for Proclarix.
• Raised approximately $6.9 million in net proceeds from a Private Placement. This change indicates a recent capital-raising activity.
• Increased state net operating loss carryforwards from approximately $12.5 million to $27.9 million. This change may impact future tax benefits.
• Reliance on third-party manufacturers for ENTADFI and Proclarix production poses risks of delays, quality issues, and interruptions.
• Violations of the Exchange Act could result in penalties ranging from $257,000 to $405,000.
• Intellectual property risks highlighted, including potential infringement issues and changes in patent laws.
• The company may face litigation or disputes due to weaknesses in internal controls.
• Accumulated deficit increased from $19.4 million to $56.8 million as of December 31, 2023. This change reflects a substantial financial burden.
• Uncertainty in accurately forecasting customer demand and managing inventory could affect revenue growth.
• Cash decreased from approximately $25.4 million to $4.6 million as of December 31, 2023. This change signifies a significant reduction in available funds.
• Failure to gain and retain market acceptance for products could lead to revenue generation challenges.
• Non-compliance with Nasdaq's minimum bid price requirement could lead to delisting.