G1 Therapeutics (GTHX) Study Update summary

Study design and objectives

• PRESERVE 2 was a phase III global clinical trial evaluating trilaciclib in combination with gemcitabine and carboplatin for metastatic triple-negative breast cancer, including both PD-L1 positive and negative subgroups.

• The primary endpoint was overall survival in the intent-to-treat population.

• Patient demographics and baseline characteristics were well balanced between arms.

Key efficacy and safety results

• The trial did not achieve statistical significance for overall survival; median OS was 17.4 months (trilaciclib) vs. 17.8 months (control), HR 0.91, P=0.884.

• No significant difference in overall survival for PD-L1 subgroups; objective response rate slightly favored control, with no difference in progression-free survival.

• Myeloprotection benefits were observed: severe neutropenia occurred in 8% (trilaciclib) vs. 29% (control); reduced grade 3/4 anemia and transfusions.

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

Strategic and operational updates

• The phase III study will be wound down, and investments in first-line TNBC will be discontinued; hiring and headcount outside the commercial team will be reduced.

• Focus will shift to expanding Cosela in extensive-stage small cell lung cancer and exploring other myeloprotection uses, with ex-US partnerships being pursued.

• Commercial efforts are driving quarter-over-quarter growth, with 15 new accounts added per quarter and 13% overall market share.

• 2024 COSELA net revenue guidance reaffirmed at $60–$70 million.

• Cost reductions and organizational streamlining are expected to extend the cash runway and support profitability in H2 2025.