G1 Therapeutics(US:GTHX)2022-09-16 21:17Trilaciclib Potential & Clinical Pipeline - Trilaciclib has the potential to improve survival in combination with leading/emerging chemotherapy treatments by myeloprotection and immunomodulation[4] - The company anticipates initial results from multiple Phase 2 trials in 4Q 2022, including 1L bladder cancer, MOA, and ADC combination trials[4] - Phase 3 data readouts are expected in 1Q 2023 for 1L CRC and in 2H 2023 for 1L TNBC[4] COSELA Commercial Performance & Market Opportunity - In 2Q22, COSELA achieved $8.7 million in net sales, with nearly 60% vial volume growth QoQ[26] - G1 estimates a total market value of ~$700 million for COSELA in ES-SCLC, with a current penetration of ~4%[28] - Approximately 30,000 ES-SCLC patients are treated annually in the US, with 17,500 in 1L, 9,500 in 2L, and 2,500 in 3L[18] - COSELA has exceptional reimbursement coverage, with approximately 60% from Medicare, 30% from Commercial, and 10% from Medicaid/Other[18] Clinical Trial Data & Ongoing Studies - In a Phase 2 trial for mTNBC, trilaciclib demonstrated robust Overall Survival (OS) improvement, with hazard ratios of 0.31 and 0.40 compared to chemotherapy alone[8, 41] - In mTNBC study, for PD-L1 positive tumors, median OS was 32.7 months for gem/carbo + trilaciclib vs 10.5 months for gem/carbo alone, with a hazard ratio of 0.34[46] - The ongoing Phase 3 PRESERVE 1 trial in 1L CRC has completed enrollment of 326 participants, with initial results expected in 1Q 2023[40] - The ongoing Phase 3 PRESERVE 2 trial in 1L TNBC has a target enrollment of ~180 participants, with an interim OS analysis expected in 2H 2023[47, 48] Financial Position & Upcoming Milestones - The company had $144 million in cash and cash equivalents as of June 30, 2022, with an additional $25 million of debt facility available[55] - G1 anticipates a $13 million milestone payment in 3Q22 for trilaciclib approval in China, with potential for up to $156 million in milestones and double-digit royalties[55]