RenovoRx, Inc. — Q1 2023 Form 10-Q
Reporting period: Three months ended March 31, 2023. RenovoRx is a clinical-stage biopharmaceutical company developing RenovoGem, an intra-arterial gemcitabine treatment using its RenovoTAMP platform. It reported no product revenue.
Financial results and liquidity
| Metric | Q1 2023 | Q1 2022 / comparator |
|---|---|---|
| Revenue | None | None |
| Research and development expense | $1.338 million | $1.289 million |
| General and administrative expense | $1.923 million | $1.716 million |
| Total operating expenses | $3.261 million | $3.005 million |
| Net loss | $3.257 million | $3.003 million |
| Basic and diluted loss per share | $0.36 | $0.33 |
| Operating cash used | $2.706 million | $2.097 million |
At March 31, 2023, cash and cash equivalents were $3.723 million, with no short-term marketable securities, versus $6.440 million in cash and securities at December 31, 2022. Total assets were $4.561 million, total liabilities $1.305 million, and stockholders’ equity $3.256 million. The filing reports no outstanding debt. The company used $2.032 million of investing cash, mainly from Treasury bill maturities, and received $6,000 from option exercises.
Operating expenses rose 9% year over year and net loss increased 8%. R&D was nearly flat: higher clinical consulting and allocated support costs were largely offset by lower trial and device-manufacturing costs, including suspension of the European Phase III trial. G&A increased 12%, reflecting higher personnel-related and professional costs. No meaningful operating margin comparison applies because the company had no revenue.
Clinical development, outlook and risks
- The company reported that the first planned interim analysis of its Phase III TIGeR-PaC pancreatic cancer trial showed a six-month median overall-survival benefit and more than 65% fewer adverse events for RenovoGem versus the control arm. The Data Monitoring Committee recommended continuing the trial without modification and reported no safety concerns. These are interim findings, not final results.
- The trial’s modified plan analyzes SBRT patients, targets 114 randomized patients and 86 deaths, and includes a second interim analysis. The company said it had not discussed the protocol amendment or modified statistical analysis plan with FDA and could not assure FDA agreement. At April 25, 2023, 50 of 114 patients had been randomized; management anticipated enrollment in 2024, a second interim analysis around mid-2024, and final results in 2025. Timing is uncertain.
- Management anticipated launching a Phase II/III study in extrahepatic cholangiocarcinoma around mid-2023, with durvalumab incorporated into the protocol under development.
- The company expects continuing and increasing losses and negative operating cash flows, and does not expect product revenue for several years, if ever. It stated that March 31 cash was not sufficient for at least the next 12 months under its planned program and that substantial doubt exists about its ability to continue as a going concern. Additional financing is necessary; availability and terms are uncertain.
- After quarter-end, the April 3 registered direct offering and concurrent private placement generated approximately $5 million gross, before fees and expenses. The transaction included 1,557,632 shares or pre-funded warrants and private warrants for up to 1,947,040 shares. The filing does not state a revised cash balance or runway after the offering.
- Disclosure controls were deemed ineffective due to previously identified material weaknesses, including insufficient accounting expertise, inadequate written procedures and review controls, and limited segregation of duties. Management planned remediation during 2023.
- Other key risks include trial enrollment and regulatory uncertainty, reliance on third parties and a single-source RenovoCath supplier, potential dilution from future financing, and possible effects of COVID-19 and broader economic conditions. No material legal proceedings were reported.
Key facts for investors to verify
- Whether FDA accepts the TIGeR-PaC protocol and statistical-plan changes, and whether interim results hold up as data mature and are audited.
- Current cash, net proceeds from the April financing, and updated cash runway and financing requirements.
- Progress toward TIGeR-PaC enrollment and the anticipated cholangiocarcinoma trial launch.
- Progress and independent validation of the internal-control remediation plan.
- Potential dilution and warrant terms, including the private warrants issued with the April financing.