G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2024 Earnings Call Transcript

Raj Malik: Hi, Laura. Yes. So in terms of the first-line TNBC we obviously can’t comment on our Phase 3 just because it’s still ongoing. However, if you refer back to the Phase 2 studies the number of cycles on the median number of cycles is around eight. But if you look at the total cumulative dose of chemo is about 50% to 60% greater when patients receive trila compared to chemotherapy alone. So in terms of your second question was, could we potentially get approval beyond the first-line indication? This is always going to be a matter of discussion once we have the data and related to the indication statement on. And obviously our approach will be to try and get as broad an approval as possible with regards to gemcitabine-carboplatin combinations which could of course span first line and beyond. But that will be a matter of discussion with the agency.

Laura Prendergast: Thanks guys.

Operator: Thank you. One moment for our next question. Our next question comes from the line of David Nierengarten from Wedbush. Your line is open.

David Nierengarten: Thanks for taking the question. I have a follow-up on the Ukrainian patients. I guess the I’m wondering if the agencies preferred to include them because it would aid in statistical analysis or provide a more robust answer. And I ask this because it would seem some moving up and the time line that events have occurred from that population. So they would contribute unless I’m wrong. So that’s the question. Thanks.

Raj Malik: Yes David? Yes. So events have occurred in those patients. And that is the reason why when you count those events the time line moved up a little bit to the end of the second quarter. We’re obviously blinded. We don’t know which you know which arm those events actually occurred in. And I think this is an open question really in terms of how to deal with patients are enrolled in Ukraine and there is really no good guidance out there. In fact from the FDA or the European agencies are starting to put something out. So I think it’s been sort of all over the board. So we put — our proposal forward and the agency clearly wants to include all the data which is what we’re doing. So yes that’s where we landed.

David Nierengarten: Okay. Thanks.

Operator: Thank you. One moment for our next question. Our next question come from the line of Steve Bersey from H.C. Wainwright. Your line is open.

Steve Bersey: Hi, everyone. This is Steve on for Edward. Congratulations on the earlier cycle of deal. So we’re just wondering whether the payments are per indication and are they going to be one-time payments? And then also what triggers the milestone payment and then the timing on those?

Jack Bailey: Yeah. Thanks, Stephen. So we are certainly excited about the deal two, it gives us the real cycle of the opportunity obviously up benefit patients. So I didn’t catch your first part in terms of the milestone, there are a combination of both of development regulatory. So those will unfold over time. Your first part of your question was…

Steve Bersey: So are the are the payments going to be per indications, different indications like you go into?

Jack Bailey: Yeah. There’s going to be multiple payments based upon multiple invitations.

Steve Bersey: Okay. Thank you.

Jack Bailey: Yeah. Thank you.

Operator: Thank you. [Operator Instructions] One moment for our next question. Tosh Hasan from Rodman & Renshaw. Your line is open.

Unidentified Analyst: Good morning. This is Tosh [ph] on for Tony Butler. If I heard correctly, I think Andrew spoke about the addition of three new headcount increases in the sales force. I wonder if you could share your thoughts about how this is expected to help with the commercial efforts in the current setting? And then I have another question.

Jack Bailey: Sure. Yeah. Thank you for the question. We always are looking at our sales force size and structure to be able to identify new opportunities and capitalize on them. And these changes were our effort to do that. I also mentioned that we added the headcount in the West for example to do exactly that to take advantage of some of the opportunities we’ve identified in many situations. In many situations, the success of COSELA relies on sales representatives gaining access to key decision makers, key prescribers as well as nursing and pharmacy staff. And so our sales team performed an invaluable role in doing that in combination with our market access team, including our strategic accounts team and then answering any questions that arise through our medical affairs team. So in many respects, the continued evolution of our sales force is absolutely critical to our success and we’re delighted to welcome those new folks into our organization.

Unidentified Analyst : That’s helpful. Thank you. The other question is about the small cell lung cancer patients beyond the frontline setting. For example, can you share with us your data and assuming that there is any the share of second line and third line markets, and also whether you see a significant number of patients being dosed with COSELA in the second and third line after having received it in the frontline setting?