G1 Therapeutics (GTHX) Study Update summary

Top-line results from PRESERVE 2 trial

• Phase III PRESERVE 2 trial in metastatic triple-negative breast cancer did not achieve statistical significance in overall survival as the primary endpoint; hazard ratio 0.91, P value 0.884.

• Median overall survival was 17.4 months for trilaciclib plus gemcitabine/carboplatin vs. 17.8 months for control.

• No significant difference in overall survival for PD-L1 positive or negative subgroups; objective response rate slightly favored control.

• No difference in progression-free survival between arms; regional and post-therapy variability observed.

• Study was well-balanced in demographics and baseline characteristics.

Myeloprotection and safety findings

• Trilaciclib showed meaningful reduction in severe neutropenia: 8% vs. 29% in control.

• Improved mean duration of severe neutropenia in cycle one for trilaciclib recipients.

• Lower rates of grade 3/4 anemia and red blood cell transfusions with trilaciclib.

• Safety profile consistent with prior studies; no new safety signals identified.

Strategic and financial updates

• Company will wind down the phase III TNBC study and discontinue investments in first-line TNBC.

• Focus shifting to expanding Cosela in small cell lung cancer and exploring other myeloprotection uses.

• Confident in achieving $60–$70 million Cosela net revenue in 2024 and profitability in H2 2025.

• Organization to be streamlined, extending cash runway and supporting profitability goals.

• Pursuing ex-US partners to expand Cosela use globally.