PAPZIMEOS Approval and Launch - PAPZIMEOS received full FDA approval in 2025 for treating all adults with RRP, regardless of disease severity[10, 14] - PAPZIMEOS is the first and only FDA-approved therapy for adults with RRP, targeting the underlying cause of the disease[16] - The company commenced the commercial US launch of PAPZIMEOS and initiated its commercial manufacturing campaign in 2025[10] - Over 50 accounts, including academic and community settings, have prescribed PAPZIMEOS[33] - The company has seen a rapid increase in unaided brand awareness of PAPZIMEOS across academic and community settings[34] Clinical Data and Efficacy - Clinical data shows a 51% complete response rate with PAPZIMEOS, with durable ongoing complete responses[21] - PAPZIMEOS significantly reduced the number of surgeries required post-treatment, with p<0001[22] - Median duration of follow-up was at 36 months (27-37), and the median duration of complete response has yet to be reached[25] Market Opportunity and Expansion - The prevalence of RRP in the US is approximately 27000 adult patients, suggesting a multi-billion-dollar revenue potential[30] - The prevalence of RRP ex-US is approximately 35000 adults in EU4, UK, and Japan, approximately 50000 adults in the rest of EU and select markets, and approximately 85000 adults in China, suggesting a multi-billion-dollar revenue potential[30] - The company anticipates PAPZIMEOS regulatory expansion to the EU and Japan[37] Financials and Future Milestones - The company secured up to $125 million in non-dilutive funding to fortify its balance sheet[10] - The company aims to achieve positive cash flow in 2026 by continuing execution and expansion to maximize the PAPZIMEOS market opportunity[37]