RenovoRx(RNXT) - 2025 Q3 - Quarterly Results

Financial Performance - Year-to-date revenue for RenovoRx reached approximately $900,000 as of September 30, 2025, reflecting growing clinical need and market demand for targeted drug-delivery solutions [2] - RenovoRx reported third quarter revenues of approximately $266,000, marking the company's third full quarter of revenue generation from RenovoCath sales [14] - The net loss for the third quarter was $2.9 million, compared to a net loss of $2.5 million for the same period in 2024 [17] - Cash and cash equivalents stood at $10 million as of September 30, 2025, sufficient to fund ongoing commercialization efforts and complete enrollment in the Phase III TIGeR-PaC clinical trial [15] Market Expansion - The number of approved cancer centers purchasing RenovoCath increased from 5 at the beginning of 2025 to 14 by November 7, 2025, with additional quotes requested from 10 more centers [4] - The initial total addressable market (TAM) for RenovoCath is estimated at approximately $400 million, with long-term potential in the several billion-dollar range as the platform expands [8] - RenovoRx has engaged with numerous physicians expressing interest in utilizing RenovoCath, indicating strong market interest and advocacy for the TAMP platform [4] Clinical Development - The Phase III TIGeR-PaC trial is on track for enrollment completion in early 2026, with final data readout expected in 2027 [10] - The company is focused on commercializing its RenovoCath and TAMP technology, with ongoing clinical trials and studies aimed at treating specific medical conditions [32] Expenses and Financial Management - Research and development expenses for the third quarter were $1.7 million, while selling, general, and administrative expenses were approximately $1.7 million [16] - There are concerns regarding the sufficiency of existing cash and cash equivalents to fund future operating expenses and capital requirements [32] Strategic Planning and Risks - There are inherent risks and uncertainties associated with the company's forward-looking statements, including the potential for clinical trials to not demonstrate sufficient safety and efficacy for regulatory approval [32] - The company emphasizes the importance of regulatory approvals and the potential impact of regulatory authorities on its clinical development plans and timelines [32] - The company is exploring commercial opportunities for its TAMP technology, but there is a risk that this may not lead to viable revenue-generating operations [32] - The company is assessing the commercialization potential of its product candidates, contingent upon regulatory approval [32] - The ability to manufacture and supply product candidates for clinical trials and commercial use is a key focus area for the company [32] - The company acknowledges the competitive landscape and the need to monitor developments related to competitors and industry trends [32] - Future strategic arrangements and collaborations are being considered to enhance the company's operational capabilities and market position [32] Team Development - The company strengthened its commercial team by hiring Philip Stocton as Senior Director of Sales & Market Development and plans to add a marketing director by the end of the year [7]