RNXT — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-13

• Unless the context otherwise requires, all references in this section to the “Company,” “we,” “us,” or “our” refer to RenovoRx, Inc

• We hold a strong and growing global intellectual property portfolio. As of June 30, 2026, we had 19 issued patents (9 US, 10 OUS), 1 allowed (US) patent and 14 published and pending patents (5 US, 7 OUS and 2 PCT) covering our TAMP platform and RenovoCath.

• Until 2025, we primarily focused our efforts on progressing our novel drug-device combination oncology product candidate, intra-arterial gemcitabine (known as "IAG") delivered via RenovoCath, through our ongoing Phase III TIGeR-PaC study for locally advanced pancreatic cancer ("LAPC"). IAG is curren…

• As the TIGeR-PaC study progressed, we received unsolicited (and subsequently solicited) feedback from oncologists, surgeons, and interventional radiologists highlighting strong interest in our technology, indicating a demand and commercial opportunity for targeted delivery of diagnostic and/or thera…

• We are actively commercializing the TAMP platform and RenovoCath as a stand-alone device. In 2025, our first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales with effectively zero sales and marketing infrastructure for the majority of the year. In the seco…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• We are actively commercializing the TAMP therapy platform and RenovoCath as a stand-alone device. In its first full year of commercial efforts, we generated approximately $1.1 million in RenovoCath sales. We saw further acceleration in the commercial rollout of RenovoCath during the first quarter of…

• Our commercial model remains centered on active cancer center expansion, with additional centers driving increased procedures and revenue growth. We began 2025 with 5 active commercial cancer centers, and by end of the year, we had grown to 8. As of May 6, 2026, we had 16 active centers. We are also…

• We continue to observe organic repeat ordering behavior from existing customers, which we view as a key indicator of physician satisfaction and clinical utility. As physicians incorporate RenovoCath into routine clinical practice, repeat utilization is expected to drive sustained and compounding rev…

• We continue to estimate that the initial total addressable market (TAM) for RenovoCath as a stand-alone device represents an approximately $400 million peak annual U.S. sales opportunity, with long-term, several-billion-dollar potential as the platform expands into additional solid tumor indications…

• We are also evaluating our novel drug-device combination oncology product candidate (intra-arterial gemcitabine delivered via RenovoCath, known as "IAG") in the ongoing Phase III TIGeR-PaC trial. IAG is being evaluated by the Center for Drug Evaluation and Research (the drug division of the FDA) und…

Text added vs the prior filing · source: 10-Q · 2026-08-13

• condition, results of operations, growth prospects or stock price. In such an event, the market price of our common stock could decline, and you may lose all or part of your investment. Additional risks and uncertainties not presently known to us or that we currently deem immaterial may also impair …

• Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we were initially provided 180 calendar days, or until June 30, 2026, to regain compliance. On July 1, 2026, we received a notification letter from Nasdaq informing us that, while we have not yet regained compliance with the Minimum Bid Price Requiremen…

• compliance with the Minimum Bid Price Requirement and the matter will be closed. In the event we do not regain compliance with the Minimum Bid Price Requirement by the end of the Compliance Period, the Listing Qualifications Department of Nasdaq will issue a Staff Delisting Determination under Nasda…

• We will continue to monitor the closing bid price of our common stock and seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods and may, if appropriate, consider available options, including implementation of a reverse stock split, to regain complia…

Text removed vs the prior filing · source: 10-Q · 2026-05-14

• revenue generating company. These factors make it difficult to evaluate our current business and predict our future success and viability.

• Pursuant to Nasdaq Listing Rule 5810(c)(3)(A), we have 180 calendar days from receipt of a notice from Nasdaq (the “Compliance Period”), to regain compliance with the Minimum Bid Price Requirement. If at any time during the Compliance Period, the bid price of our common stock closes at or above $1.0…

• We will continue to monitor the closing bid price of our common stock and seek to regain compliance with all applicable Nasdaq requirements within the allotted compliance periods and may, if appropriate, consider available

• options, including implementation of a reverse stock split, to regain compliance with the Minimum Bid Price Requirement or the Low Priced Stocks Rule, as applicable. A reverse stock split, if implemented, could have a material adverse effect on our stock price and valuation.