RenovoRx(US:RNXT)2025-11-13 21:12Financial Performance - Revenues for the three months ended September 30, 2025, were $266,000, compared to $0 for the same period in 2024, indicating a significant increase [22]. - Gross profit for the nine months ended September 30, 2025, was $586,000, compared to $0 for the same period in 2024, reflecting successful revenue generation [22]. - The net loss for the three months ended September 30, 2025, was $2,912,000, compared to a net loss of $2,471,000 for the same period in 2024, indicating a 17.8% increase in losses [22]. - For the nine months ended September 30, 2025, the company reported a net loss of $8.2 million, compared to a net loss of $5.9 million for the same period in 2024 [29]. - The company reported a net loss of $8,227,000 for the nine months ended September 30, 2025, compared to a net loss of $5,936,000 for the same period in 2024, representing a 38.6% increase in net loss [89]. - The company anticipates continued operating losses until significant revenue is generated from the commercialization of the RenovoCath device [166]. Assets and Liabilities - Total assets increased to $11,206,000 as of September 30, 2025, up from $8,118,000 on December 31, 2024, representing a 37.5% growth [17]. - Cash and cash equivalents increased to $10,044,000 as of September 30, 2025, up from $7,154,000 on December 31, 2024, a growth of 40.5% [17]. - Total liabilities decreased to $3,128,000 as of September 30, 2025, down from $3,640,000 on December 31, 2024, a reduction of 14.0% [18]. - The accumulated deficit as of September 30, 2025, was $(58,446,000), compared to $(50,219,000) as of December 31, 2024, indicating an increase in the deficit of 16.4% [19]. Expenses - Operating expenses for the three months ended September 30, 2025, totaled $3,413,000, an increase from $2,828,000 in the same period of 2024, marking a 20.6% rise [22]. - Research and development expenses for the nine months ended September 30, 2025, were $4,768,000, compared to $4,449,000 for the same period in 2024, a 7.2% increase [22]. - Selling, general and administrative expenses increased by 47% to approximately $1.7 million for the three months ended September 30, 2025, compared to $1.2 million for the same period in 2024 [154]. - Selling, general and administrative expenses for the nine months ended September 30, 2025, were approximately $4.8 million, a 24% increase from $3.9 million in the same period in 2024 [156]. Financing Activities - The company raised an aggregate of $71.4 million since its inception, with net proceeds of $64.3 million after deducting offering expenses [35]. - The company completed a registered direct offering in April 2023, raising gross proceeds of $5.0 million [40]. - The February 2025 public offering generated approximately $12.1 million in gross proceeds, with net proceeds of $10.8 million after deducting underwriting fees and expenses [43]. - The company anticipates needing additional funding to support operations if commercial sales of RenovoCath do not significantly increase during 2026 [45]. Commercialization and Market Potential - The company expanded its commercial efforts for the RenovoCath device, achieving its first commercial sales revenue in Q4 2024 and increasing the number of approved centers from 5 to 14 by early 2025 [105]. - The initial peak U.S. market opportunity for RenovoCath is estimated at approximately $400 million annually, with potential for several billion dollars as the company expands into other tumor types [111]. - As of September 30, 2025, RenovoCath sales totaled approximately $900,000, with expectations for revenue growth over time [106]. Clinical Trials and Research - The ongoing Phase III TIGeR-PaC clinical trial for IAG is expected to complete enrollment in early 2026, with final data anticipated in 2027 [114]. - The company launched the RR5 Post-Marketing Registry Study in July 2025 to evaluate the safety and effectiveness of RenovoCath across a range of solid tumors [121]. - The independent Data Monitoring Committee recommended continuing the TIGeR-PaC trial after their second interim analysis in August 2025 [117]. Internal Controls and Governance - The company has identified material weaknesses in its accounting policies and controls, primarily due to insufficient staffing and lack of GAAP expertise [189]. - The remediation plan includes hiring additional accounting personnel with GAAP and SEC reporting experience and developing an accounting policy manual [190]. - The company plans to enhance internal control procedures and monitoring for complex transactions to ensure financial statement accuracy [191]. - There have been no changes in internal control over financial reporting that materially affect the company since the filing of the 2024 Annual Report [193]. Stock and Shareholder Information - The company reported a weighted-average share count of 36,646,278 for the three months ended September 30, 2025, compared to 24,940,746 for the same period in 2024, reflecting a 46.0% increase in shares outstanding [22]. - The common stock warrant liability was valued at $1.1 million as of September 30, 2025, compared to $1.5 million as of December 31, 2024 [59]. - The market price of the company's common stock may be volatile, and failure to comply with Nasdaq requirements could lead to delisting [202].