RenovoRx files NT 10-K, says annual report will be late

RenovoRx, Inc. (Nasdaq: RNXT) said on March 31, 2025 that it cannot file its annual report on Form 10-K for the year ended December 31, 2024 on time. In a Form NT 10-K notification of late filing, the company said it needs more time to finish certain technical accounting requirements with its current and former auditing firms. It expects to file within the fifteen-day grace period that Rule 12b-25 allows.

What the filing says

Form NT 10-K, also called Form 12b-25, is the form a public company files when it cannot complete a periodic report by the due date. RenovoRx checked the box for relief under Rule 12b-25(b). That choice means the company says it will file the report on or before the fifteenth calendar day after the prescribed due date.

The reason given in Part III is short. RenovoRx says it is unable to file the Form 10-K without unreasonable effort or expense because of the need to complete certain technical accounting requirements with its current and former auditing firms. The company also answered "Yes" to the question of whether all other periodic reports required in the preceding 12 months have been filed.

Preliminary comments on results

The form asks whether a significant change in results is expected compared with the prior year. RenovoRx answered yes and gave a narrative outline. It expects to recognize small initial revenue from its RenovoCath commercial efforts for the year ended December 31, 2024, compared with the year ended December 31, 2023. It also expects a small decrease in net loss, due in part to a reduction in selling, general, and administrative expenses.

The company cautions that these amounts are still under review by its independent registered public accounting firm and its accounting staff. They may differ once reported in the Form 10-K.

Who signed

Vice President, Controller and Principal Accounting Officer Ronald B. Kocak signed the notice for RenovoRx on March 31, 2025. The filing lists Shaun R. Bagai as the person to contact about the notification.

About the company

RenovoRx describes itself in its Form 10-K filed April 1, 2024 as a clinical-stage biopharmaceutical company developing targeted combination therapies for cancer patients. Its Trans-Arterial Micro-Perfusion (TAMP) platform is designed to deliver therapy directly to the tumor while potentially minimizing the toxicities of intravenous therapy.

The lead product candidate is RenovoGem, an oncology drug-device combination product being evaluated for locally advanced pancreatic cancer. It is in a Phase III registrational trial called TIGeR-PaC. The company says RenovoGem received FDA Orphan Drug Designation for pancreatic cancer and bile duct cancer, which provides 7 years of market exclusivity upon approval of a New Drug Application.

The company says its earlier RR1 Phase I/II and RR2 observational registry studies enrolled 20 and 25 patients, and showed a median overall survival of 27.9 months in patients pre-treated with radiation and then given RenovoGem. It adds that those trials did not prospectively control the standard of care patients received beforehand, unlike the randomized trials behind the 12 to 15 month expectation for standard therapy.

Going concern history

That 10-K included an auditor's report with a section on substantial doubt about the company's ability to continue as a going concern. It said RenovoRx had incurred significant losses and negative cash flows from operations since its inception. The auditor noted a net loss of $10.2 million for the year ended December 31, 2023 and an accumulated deficit of $41.4 million as of that date.

The 10-K was signed by Chief Executive Officer and Director Shaun R. Bagai, and its signature page lists Ramtin Agah as Chairman of the Board of Directors.

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