Novocure (NASDAQ: NVCR) announced today that the final patient has been enrolled in the global phase 3 Trident clinical trial evaluating the safety and efficacy of initiating Optune Glio® (formerly known as Optune®) concurrent with radiation therapy and temozolomide (TMZ) for the treatment of adult patients with newly diagnosed glioblastoma (GBM).
Asaf Danziger, Novocure's Chief Executive Officer, expressed, "TTFields therapy has played a critical role in the treatment of newly diagnosed glioblastoma for nearly a decade, and the Trident trial represents the potential evolution of this treatment paradigm by introducing TTFields earlier, at the same time as radiation therapy and temozolomide. Preclinical research has shown that the application of TTFields together with radiation therapy leads to a more pronounced cytotoxic effect in glioma cell lines as compared to TTFields after administration of radiation therapy. The Trident study could unlock our ability to reach patients earlier in their treatment journey, further extending patient survival. We remain committed to exploring opportunities to further extend the survival horizon for patients diagnosed with glioblastoma."
Optune Glio® is currently approved for use together with maintenance TMZ for the treatment of newly diagnosed GBM following maximal debulking surgery and the completion of radiation therapy.
The Trident clinical trial is a randomized, open-label study designed to enroll 950 adult patients with newly diagnosed GBM. Final data from the Trident trial is anticipated in 2026, with the trial's primary endpoint being overall survival. Secondary endpoints include progression-free survival, one-year and two-year survival rate, overall radiological response, next progression-free survival, and other measures related to adverse events and quality of life.
Novocure is a global oncology company focused on extending survival in aggressive forms of cancer through the development and commercialization of innovative therapy, tumor treating fields. The company has ongoing or completed clinical trials investigating tumor treating fields in various types of cancer, including brain metastases, gastric cancer, liver cancer, non-small cell lung cancer, pancreatic cancer, and ovarian cancer.
Novocure's stock moved -0.8% following the announcement and is currently trading at a price of $14.73 per share.
The company's full 8-K submission is available here.
| 2018 | 2019 | 2020 | 2021 | 2022 | 2023 | |
|---|---|---|---|---|---|---|
| Revenue (k) | $248,069 | $351,318 | $494,366 | $535,031 | $537,840 | $503,983 |
| Revenue Growth | n/a | 41.62% | 40.72% | 8.23% | 0.53% | -6.29% |
| Operating Margins | -14% | 0% | 6% | -8% | -17% | -44% |
| Net Margins | -26% | -2% | 4% | -11% | -17% | -39% |
| Net Income (k) | -$63,559 | -$7,230 | $19,808 | -$58,351 | -$92,534 | -$197,267 |
| Net Interest Expense (k) | $12,270 | $7,910 | $12,299 | $7,742 | $8,113 | $7,677 |
| Depreciation & Amort. (k) | $9,006 | $8,460 | $9,150 | $10,251 | $10,624 | $10,947 |
| Earnings Per Share | $91828043.0 | -$0.07 | $0.18 | -$0.56 | -$0.88 | -$1.86 |
| Free Cash Flow (k) | -$8,576 | $16,135 | $84,180 | $58,586 | $9,430 | -$89,188 |
| Capital Expenditures | $6,711 | $10,485 | $14,968 | $24,170 | $21,358 | $26,703 |
| Current Ratio | 4.98 | 5.1 | 8.8 | 7.53 | 7.0 | 6.67 |
NovoCure has consistently negative margins with a negative growth trend, declining EPS growth, and irregular cash flows. On the other hand, the company has growing revenues and increasing reinvestment in the business working in its favor.
