RESEARCH TRIANGLE PARK - G1 Therapeutics, Inc. (NASDAQ:GTHX), a commercial-stage oncology company, announced today that its Phase 3 PRESERVE 2 trial for metastatic triple-negative breast cancer (TNBC) did not meet the primary endpoint of overall survival in the intent-to-treat population.
The study evaluated the efficacy and safety of trilaciclib, administered before chemotherapy, in 187 patients but failed to show a statistically significant improvement in survival rates.
The median overall survival was 17.4 months for patients treated with trilaciclib in combination with chemotherapy, compared to 17.8 months for the control arm. While the outcomes in subgroups based on PD-L1 status were not statistically significant, the company noted a numerical favor towards the trilaciclib arm. Regional variations and differences based on subsequent therapies were observed, which will be subject to further analysis.
Despite the trial's results, trilaciclib demonstrated a consistent safety profile and provided myeloprotection, reducing severe neutropenia rates to 8% from 29% in the control group. G1 Therapeutics plans to present detailed findings at a future medical conference.
Following these results, CEO Jack Bailey expressed disappointment but gratitude towards participants, their families, and healthcare providers. He indicated that the company would now concentrate on expanding its extensive-stage small cell lung cancer (ES-SCLC) business and exploring other applications for trilaciclib. Efforts to seek partners outside the U.S. to increase the global use of COSELA® (trilaciclib) are also underway.
Financially, G1 Therapeutics reaffirmed its 2024 revenue guidance for COSELA, projecting net revenues between $60 million and $70 million. The company is taking strategic steps, including discontinuing certain investments and making targeted headcount reductions, to streamline operations and extend its cash runway. These measures are expected to support the company's path to profitability in the second half of 2025.
The information in this article is based on a press release statement from G1 Therapeutics.
In other recent news, G1 Therapeutics reported a 34% increase in net sales year-over-year in their first-quarter earnings call for 2024, along with a 4% increase in vial volume growth for their flagship product, COSELA. The company maintains net sales guidance of $60 million to $70 million for the year and is optimistic about achieving profitability and positive cash flow in the next year.
In addition to these developments, G1 Therapeutics has secured a licensing deal with Pepper Bio that could bring in up to $135 million in payments. The company also highlighted upcoming clinical trials that could provide significant data and potentially lead to partnerships and supplemental NDA filing with the FDA.
InvestingPro Insights
As G1 Therapeutics, Inc. (NASDAQ:GTHX) navigates through the challenges of its recent clinical trial outcomes, investors are closely monitoring the financial health and market sentiment surrounding the company. According to InvestingPro data, G1 Therapeutics holds a market capitalization of $129.66 million, which provides a perspective on the company's size in the competitive oncology space. The data also reveals a striking gross profit margin of 91.89% over the last twelve months as of Q1 2024, underscoring the company's ability to maintain high margins despite the current setbacks.
While G1 Therapeutics does not expect to be profitable this year, with an adjusted P/E ratio of -4.24, it is noteworthy that the company holds more cash than debt on its balance sheet, an InvestingPro Tip that suggests a degree of financial stability in its operations. Moreover, 4 analysts have revised their earnings upwards for the upcoming period, indicating a potential shift in expectations despite analysts anticipating a sales decline in the current year.
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