Summary of XORTX Therapeutics Webinar Company Overview - **Company**: XORTX Therapeutics (NasdaqCM:XRTX) - **Focus Areas**: Development of therapies for gout and autosomal dominant polycystic kidney disease (ADPKD) [9][12] Core Points and Arguments Gout Program - **Primary Focus**: Developing a formulation of oxypurinol for gout treatment, targeting allopurinol-intolerant patients [9][11] - **Market Opportunity**: Estimated at $700 million for allopurinol-intolerant gout patients, filling a gap left by febuxostat [11][15] - **Clinical Background**: The drug has a safe and effective clinical record established in over 800 patients [12] - **Regulatory Path**: Preparing to file a New Drug Application (NDA) within the next 12 to 14 months, with a review period of 9 to 12 months [19][26] - **Patient Demographics**: Approximately 50 million individuals have high uric acid levels, with 7 to 9 million diagnosed with gout [14] - **Pricing Strategy**: Projected launch price between $6,000 and $8,000 per patient per year [15] ADPKD Program - **Market Opportunity**: Estimated at $1 to $1.5 billion, with a focus on patients with high uric acid levels [12][24] - **Regulatory Path**: A single small registration trial may suffice for FDA approval [12] - **Current Treatment Landscape**: Tolvaptan is the only approved drug, costing $156,000 per patient per year, treating only 5% of patients [23][25] - **Potential Market Size**: Estimated peak net sales could exceed $1 billion by treating around 18,000 individuals [25] Development and Manufacturing - **Key Activities**: Preparing an Investigational New Drug (IND) application and conducting pharmacokinetic studies [10][20] - **Manufacturing Plans**: A year of stability testing is required before NDA filing [21][26] - **Team Expertise**: Strong developmental team with experience in drug development and commercialization [27][28] Additional Important Information - **Patent Protections**: Recent EU patent grants cover major countries, with U.S. patents extending through 2034 and additional layers through 2041 and 2043 [34][35] - **Commercialization Strategy**: Plans to establish manufacturing and distribution contracts in preparation for the product launch [36] - **Market Capitalization**: Currently around $4 million to $5 million, with potential for significant value creation as the NDA is submitted [38][39] Conclusion - **Investment Opportunity**: XORTX Therapeutics is positioned for growth with low-risk activities planned over the next 12 to 24 months, aiming to transition from a research-focused company to a revenue-generating entity [39]