G1 Therapeutics, Inc. (NASDAQ:GTHX) Q3 2018 Earnings Conference Call Transcript

Nov 07, 2018 • 04:30 pm ET

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G1 Therapeutics, Inc. (NASDAQ:GTHX) Q3 2018 Earnings Conference Call Transcript

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Presentation
Operator
Operator

Good day, ladies and gentlemen, and welcome to the G1 Therapeutics Third Quarter 2018 Financial Results Call. At this time, all participants are in a listen only mode. Later we will conduct the question-and-answer session and instructions will be given at that time. (Operator Instructions) As a reminder, this call is being recorded.

I would now like to turn the call over to Jeff Macdonald. You may begin.

Executive
Jeff Macdonald

Thank you, operator. Good afternoon, everyone, and welcome to the G1 Therapeutics third quarter 2018 financial results and corporate update. Joining me are Mark Velleca, CEO; Raj Malik, CMO and SVP, R&D; and Buck Phillips, CFO and SVP, Corporate Development.

(Forward-Looking Cautionary Statement)

I'll now turn the call over to Mark.

Executive
Mark Velleca

Thank you, Jeff. Good afternoon, everyone, and thanks for joining us today. In the third quarter of 2018, the company focused on execution of clinical trials across all three product candidates in our pipeline: trilaciclib, lerociclib and G1T48. On today's call, I'll provide a brief status update on our programs, and Raj will discuss upcoming data readouts for trilaciclib. Buck will review our financials, and then we'll open the call for questions.

Starting with trilaciclib. In March, we announced positive Phase 2 top line data showing robust myelopreservation benefits in first line small cell lung cancer. Last month at ESMO, we presented new analysis of that trial demonstrating that trilaciclib reduced duration of severe neutropenia and red blood cell transfusions. In addition, we presented the first clinical data on trilaciclib's effect on lymphocytes. We saw improvements across a number of lymphocyte subsets in the trilaciclib arm compared to the placebo arm.

Importantly, trilaciclib improved activated CD8 positive T-cell counts and increased the activated CD8 positive to regulatory T-cell ratio in peripheral blood. These data support our hypothesis that trilaciclib may improve immune system function, and therefore increase overall survival when combined with chemotherapy checkpoint regiments. We are currently assessing this in our trilaciclib/chemotherapy/Tecentriq trial in first line small cell lung cancer.

While overall survival data from the trilaciclib/chemotherapy/Tecentriq trial will not be mature until next year, we will report myelopreservation response rate and preliminary PFS data by the end of the year. This is an addition to reporting data from two other randomized Phase 2 trials by year-end. Raj will review our trilaciclib clinical program in more detail momentarily.

I'll now turn to lerociclib, our oral CDK4/6 inhibitor. We currently have two clinical trials enrolling. The Phase 2a portion of our lerociclib plus Faslodex trial in ER-positive, HER2-negative breast cancer, and the Phase 1b dose escalation portion of our lerociclib plus Tagrisso trial in non-small cell lung cancer. Enrollment is on track, and we expect to report data from both programs in 2019.

Finally, we are continuing the dose escalation portion of our Phase 1/2 clinical trial of G1T48, our oral selective estrogen receptor degrader, or SERD. We expect to complete enrollment of the Phase 1 dose escalation portion of the trial, which is evaluating G1T48 as monotherapy in ER-positive HER2-negative breast