RenovoRx — Third Quarter 2026 Earnings Summary

Financial Performance:

• Revenue for the quarter ended September 30, 2026, was $1.07 million, a nearly 300% year-over-year increase and 17% sequential increase from the prior quarter.
• Gross profit was $878,000, representing a gross margin of approximately 82%, compared to approximately 80% in the same period in 2025.
• Research and development expenses were approximately $1.2 million, down from approximately $1.7 million in the prior year period.
• Selling, general, and administrative expenses were approximately $2.9 million, up from approximately $1.7 million in the prior year period.
• Loss from operations was approximately $3.2 million, consistent with the $3.2 million loss reported in the same period in 2025.
• Net loss per share was $0.08 for the quarter, matching the $0.08 loss per share reported in the prior year period.
• Cash and cash equivalents totaled approximately $10.4 million as of September 30, 2026, an increase from $9.5 million as of June 30, 2026, driven by $3.5 million received from the exercise of outstanding common stock warrants.
• Total assets were $12.4 million as of September 30, 2026, compared to $8.1 million as of December 31, 2025.
• Total liabilities were $3.2 million as of September 30, 2026, compared to $2.7 million as of December 31, 2025.
• Stockholders' equity was $9.3 million as of September 30, 2026, compared to $5.4 million as of December 31, 2025.

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 believes current cash resources are sufficient to fund operations into the second half of 2027.
• RenovoRx anticipates initial top-line data from the Phase III TIGeR-PaC trial in the second half of 2027.
• The Company targets 36 active commercial cancer centers by the end of 2026, up from 26 at the end of the third quarter.

Business Segments and Product Lines:

• RenovoRx commercializes RenovoCath, an FDA-cleared drug-delivery device, and evaluates the TAMP platform for targeted oncology applications.
• Active commercial cancer center customers increased to 26 at the end of the third quarter, up from 21 at the end of the second quarter.
• The total commercial funnel has grown to more than 65 centers.
• The TAMP platform is being expanded beyond locally advanced pancreatic cancer, with the first commercial clinical use in a solid tumor beyond pancreatic cancer (sarcoma) occurring in August 2026.
• The Phase III TIGeR-PaC trial, evaluating intra-arterial gemcitabine (IAG) via RenovoCath for locally advanced pancreatic cancer, achieved full enrollment in August 2026.
• A new Investigator Initiated Trial (PRISM-TAMP) led by the University of Vermont began patient enrollment in October 2026 to evaluate TAMP in the neoadjuvant setting for pancreatic cancer.
• RenovoRx added two peer-reviewed publications in the third quarter supporting the TAMP platform's efficacy and safety.
• The U.S. Patent and Trademark Office issued a Notice of Allowance for a new patent covering the RenovoCath dual-occlusion catheter system in August 2026, bringing the portfolio to 10 issued or allowed U.S. patents.
• RenovoCath with gemcitabine and oxaliplatin received Orphan Drug Designation for pancreatic cancer and bile duct cancer.

Market and Competitive Landscape:

• The Company is strategically deploying a fully staffed sales team, including a Vice President of Sales and Market Development and five Regional Market Development Managers, to cover major U.S. cancer centers.
• Strong repeat ordering from existing customers signals physician satisfaction and clinical utility in interventional oncology.
• The TAMP platform allows for the delivery of established drugs locally and sequentially or concurrently with novel therapies, potentially improving patient outcomes.
• The Company views physician-driven expansion as an indicator of potential broader adoption of RenovoCath within its FDA-cleared fields of use.

Risks and Challenges:

• Forward-looking statements regarding clinical trials, revenue forecasts, and cash runway are subject to significant risks and uncertainties, including the possibility that actual results may differ materially from projections.
• Risks include the potential failure of commercial efforts to achieve revenue forecasts or the expected number of active cancer center customers.
• There is a risk that clinical trials may not demonstrate sufficient safety and efficacy to support regulatory approval.
• Regulatory authorities may disagree with the Company's interpretation of data or clinical development plans.
• The Company faces risks related to the timing of regulatory filings, the ability to retain key personnel, and the scope of intellectual property protection.
• Risks also include the ability to successfully manufacture and supply products, future reimbursement levels, and competition from other product candidates.

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, an increase in active commercial customers to 26, and physician-driven expansion of the TAMP platform.
• Bagai expressed confidence in the ability to meet the year-end 2026 target of 36 active commercial cancer centers.
• Management noted that the sales team is sufficiently sized to address the market and effectively penetrate cancer centers treating solid tumors.
• The tone regarding the TAMP platform is optimistic, citing its potential to make novel improved therapies even more valuable and drive sustained revenue growth through repeat utilization.

Other Key Points:

• The increase in cash and cash equivalents was driven by $3.5 million received from the exercise of outstanding common stock warrants.
• Shares outstanding totaled 48,190,073 as of September 30, 2026.
• The Company completed enrollment in the Phase III TIGeR-PaC trial in August 2026.
• A sub-study of the Phase III trial regarding pharmacokinetic and pharmacodynamic data was published in Cancer Chemotherapy and Pharmacology in August 2026.
• A peer-reviewed case series from Hackensack Meridian Health was published in Case Reports in Oncology in October 2026.
• The Company is conducting a multi-center post-marketing registry study to generate real-world safety and efficacy data for TAMP.
• Investigator Initiated Trials (IITs) are being supported in borderline resectable and metastatic pancreatic cancer and cholangiocarcinoma to broaden the platform's evidence base.