Nov 5, 2026, 4:16 PM ETHealthcare
RenovoRx — Third Quarter 2026 Earnings Summary
Financial Performance
- Revenue for the three months ended September 30, 2026, was $1.07 million, a nearly 300% year-over-year increase compared to $266,000 in the same period in 2025, and a 17% sequential increase from the second quarter of 2026.
- Gross profit was $878,000, representing a gross margin of approximately 82%, compared to approximately 80% in the third quarter of 2025.
- Research and development expenses were approximately $1.2 million for the quarter, down from approximately $1.7 million in the third quarter of 2025.
- Selling, general, and administrative expenses were approximately $2.9 million for the quarter, up from approximately $1.7 million in the third quarter of 2025.
- Loss from operations was approximately $3.2 million for the quarter, consistent with the $3.2 million loss reported in the third quarter of 2025.
- Net loss per share was $0.08 for the three months ended September 30, 2026, compared to $0.08 in the same period in 2025.
- Cash and cash equivalents totaled approximately $10.4 million as of September 30, 2026, an increase from approximately $9.5 million as of June 30, 2026.
- The increase in cash was driven by $3.5 million received from the exercise of outstanding common stock warrants, which offset cash used in operations.
- Shares outstanding totaled 48,190,073 as of September 30, 2026.
Guidance and Future Outlook
- The Company maintains full-year 2026 revenue guidance of $3.75 million to $4.25 million.
- This guidance implies year-over-year revenue growth of approximately 241% to 286% compared to full-year 2025 revenue of $1.1 million.
- Management expects full-year 2026 revenue to more than triple 2025 revenue at the midpoint.
- The Company targets reaching 36 active commercial cancer centers by the end of 2026.
- Cash resources are believed to be sufficient to fund operations into the second half of 2027.
- Initial top-line data from the Phase III TIGeR-PaC trial is anticipated in the second half of 2027.
Business Segments and Product Lines
- Active commercial cancer center customers increased to 26 at the end of the third quarter of 2026, up from 21 at the end of the second quarter of 2026.
- The total commercial funnel has grown to more than 65 centers.
- RenovoRx observed strong repeat ordering from the majority of existing customers, signaling physician satisfaction and clinical utility.
- The Trans-Arterial Micro-Perfusion (TAMP) platform enabled by RenovoCath is expanding beyond locally advanced pancreatic cancer.
- In August 2026, TAMP was deployed in the first commercial clinical use for a solid tumor beyond pancreatic cancer (sarcoma) at an existing commercial customer.
- In October 2026, the first patient was treated in the PRISM-TAMP Investigator Initiated Trial (IIT) led by the University of Vermont, evaluating gemcitabine delivery in the neoadjuvant setting for planned surgical resection.
- The Company supports IITs in borderline resectable and metastatic pancreatic cancer and cholangiocarcinoma to broaden the evidence base.
- RenovoCath received Orphan Drug Designation (ODD) for pancreatic cancer and bile duct cancer, and oxaliplatin received ODD for pancreatic cancer.
Market and Competitive Landscape
- The fully staffed sales team, consisting of a Vice President of Sales and Market Development and five Regional Market Development Managers, is strategically deployed to cover major U.S. cancer centers.
- The sales team is sized to effectively penetrate cancer centers treating solid tumors, such as pancreatic cancer.
- The Company views physician-driven expansion of the TAMP platform as an encouraging indicator of potential for broader adoption within FDA-cleared fields of use.
- The TAMP platform allows for the delivery of established drugs locally and sequentially or concurrently with novel therapies, creating potential for improved patient outcomes.
Risks and Challenges
- Forward-looking statements regarding clinical trials, commercialization, and financial results are subject to risks and uncertainties that could cause actual results to differ materially.
- Risks include the possibility that commercial efforts may not achieve revenue forecasts or the expected number of active cancer center customers.
- Risks include the timing and results of clinical trials, including the Phase III TIGeR-PaC trial, and the potential that interim results may not predict final outcomes.
- Risks include the possibility that regulatory authorities may disagree with data interpretations or that product candidates may not demonstrate sufficient safety and efficacy for approval.
- Risks include the ability to secure additional financing, maintain Nasdaq listing, and retain key personnel.
- Risks include the scope of intellectual property protection and the ability to manufacture and supply products.
Management Commentary and Tone
- CEO Shaun Bagai stated the Company generated record results in the third quarter, exceeding the million-dollar revenue threshold.
- Management highlighted three core priorities: four-fold year-over-year revenue growth, growth in active commercial customers to 26, and physician-driven expansion of the TAMP platform.
- Management expressed confidence in meeting the year-end 2026 target of 36 active commercial centers.
- Management noted that the sales team is gaining traction and accelerating customer engagement and adoption of TAMP.
- Management views the conversion of devices from the TIGeR-PaC trial to commercial centers as a driver of growth, noting that such conversions occur at no gross margin in accordance with GAAP.
Other Key Points
- The Company received a Notice of Allowance from the U.S. Patent and Trademark Office for a new patent covering the RenovoCath dual-occlusion catheter system in August 2026.
- The Company's intellectual property portfolio now includes 10 issued or allowed U.S. patents, 10 issued OUS patents, 6 pending U.S. cases, 7 pending OUS cases, and 2 pending PCT applications.
- Two peer-reviewed publications were added to the evidence base in the third quarter: PK-PD data from the TIGeR-PaC sub-study published in Cancer Chemotherapy and Pharmacology and a case series from Hackensack Meridian Health published in Case Reports in Oncology.
- The Phase III TIGeR-PaC trial achieved full enrollment in August 2026, evaluating intra-arterial gemcitabine (IAG) for locally advanced pancreatic cancer with overall survival as the primary endpoint.
- The Company completed enrollment in the Phase III TIGeR-PaC trial and anticipates the data readout to potentially expand clinical adoption by providing evidence on tolerability and reduced side effects.
- The Company is building the evidence base for TAMP through a multi-center post-marketing registry study and capital-efficient IITs.