Good day, and thank you for standing by. Welcome to the G1 Clinical Trial Update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question, you will need to press star one one on your telephone. You will then hear an automated message advising your hand is raised. To withdraw your question, please press star one one again. Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker today, Will Roberts, Communications Officer. Please go ahead. Thank you, [Siobhan]. Good morning, everyone, and welcome to the G1 conference call to discuss the results of our PRESERVE 2 clinical trial. The press release on these clinical results was issued this morning and can be found in the news section of our corporate website, g1therapeutics.com. A Q&A session will follow the prepared remarks. Before we begin, I'd like to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements represent management's judgment as of today and may involve risk and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risk and uncertainties, please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, June 24, 2024. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Dr. Raj Malik, our Chief Medical Officer. Andrew Perry, our Chief Commercial Officer, and John Umstead, our Chief Financial Officer, are also available for questions following the prepared comments. With that, I'll turn the call over to Jack. Thanks, Will. Good morning, everyone, and thank you for joining us on the call to discuss the top-line results from PRESERVE 2. Please note that the prepared comments during this call will be brief, as the results are new and we are still analyzing them. As you saw from this morning's press release, our phase III trial in triple-negative breast cancer did not achieve statistical significance in its primary endpoint of overall survival. Raj will discuss the results in a moment. We are certainly disappointed that the trial did not produce the results that we had anticipated for people living with triple-negative breast cancer. I want to commend the clinical development team responsible for conducting this global clinical trial. This was a well-designed and well-executed trial, despite the results. Most importantly, I want to express our gratitude to the patients who participated in this trial, as well as their families, and also thank the healthcare teams involved in the conduct of this trial. As a company, we will further our focus on accelerating and expanding the growth of the Cosela business in extensive stage small cell lung cancer, not only here in the U.S., but also potentially through other ex-U.S. partnerships. We are also evaluating other myeloprotection uses for the drug. Given these and other efforts, we believe that we are currently sufficiently funded to achieve profitability in the second half of next year. I'll now turn the call over to Raj for a little more color on the trial. Raj? Thanks, Jack, and good morning to everyone on the call. While we all understand the risks of drug development, particularly in difficult-to-address indications like triple-negative breast cancer, these top-line results are unexpected. As we announced in the press release, the PRESERVE 2 trial did not demonstrate a statistically significant treatment effect in the intent-to-treat population. The median overall survival in the trilaciclib plus gemcitabine carboplatin arm was 17.4 months, compared to 17.8 months in the control arm. The hazard ratio for the final overall survival analysis was 0.91, with a P value of 0.884. While the median survival in the placebo arm was longer than our expectation based on historical data, including that of the KEYNOTE-355 trial, trilaciclib did not add to that survival. There was no statistically significant difference in overall survival between the arms for both PD-L1 positive and negative subgroups, although the median overall survival numerically favored the trilaciclib arm in both subgroups. While the objective response rate slightly favored the control arm, there was no difference in progression-free survival between the two arms of the trial. We observed varying effects across regions and for patients who received subsequent therapies. Additional work is ongoing to evaluate and understand this variability. Consistent with other trilaciclib studies, we observed continued clinical evidence of myeloprotection, as one would expect, given the mechanism of action of trilaciclib. For example, we saw a meaningful reduction in the occurrence of severe neutropenia, which occurred in 29% of patients in the control arm and in only 8% of patients who received trilaciclib. Among other myeloprotection trends, we observed that the mean duration of severe neutropenia in cycle one was improved in patients receiving trilaciclib compared to the control arm. And the rate of grade three or four anemia and red blood cell transfusions was reduced among patients receiving trilaciclib compared to patients in the control arm. The safety profile of trilaciclib with gemcitabine and carboplatin observed in PRESERVE 2 was consistent with the data we've generated in prior studies, and no new safety signals were identified. Regarding patient demographics and baseline characteristics, it was a well-balanced study. These efficacy results are disappointing, particularly given the strong phase II data that preceded this trial. Unfortunately, this underscores the difficulty that we and many others have experienced in developing new drugs for this indication. We'll continue to evaluate these data, and we plan to submit them to a future medical conference. We are very grateful to all the trial participants and their families and caregivers. I also want to recognize the efforts of the trial investigators and their office staff, our partners at Simcere and the G1 team. With that, I'll turn the call back over to Jack. Thank you, Raj. As I mentioned at the start of the call, our focus is on accelerating and expanding the growth of the extensive-stage small cell lung cancer business globally. We will also evaluate other myeloprotection uses for the drug, including potential opportunities to expand the current label. These include combination with lurbinectedin in extensive-stage small cell lung cancer, and assessing survival through our global second-line topotecan study. And as we will discuss in our financial call in a few weeks, usage and adoption of Cosela continues to expand with good quarter-on-quarter growth. We have a lot of room to grow as we work to further penetrate the $700 million total addressable market here in the U.S. Regarding the elements of our guidance, this morning, we reiterated that we feel confident in achieving between $60 million and $70 million in Cosela net revenue in 2024. Additionally, G1 will wind down this phase III study, discontinue investments toward a first-line TNBC indication, and streamline the organization to support our small cell efforts. In doing so, our cash runway has been meaningfully extended, which positions us well to achieve anticipated company profitability in the second half of 2025. We are also now actively engaging with potential partners to further expand the global availability of Cosela, which we believe will provide yet another potential avenue for revenue and earnings growth. With that, I'll now turn the call over to Q&A. Operator, would you please remind our listeners how to ask a question? Thank you. At this time, we will conduct the question-and-answer session. As a reminder, to ask a question, you will need to press star one, one on your telephone and wait for your name to be announced. To withdraw your question, please press star one, one again. Please stand by while we compile the Q&A roster. Our first question comes from Joseph Thome from TD Cowen. Your line is open. Hi there. Good morning. Thank you for taking my questions and, sorry to hear the update. Maybe just on the, the lurbinectedin, combination opportunity that you indicated, can you go into a little more detail about what, what that would be, what will be needed there? And in light of that, how much do you think you could kind of cut spend either on R&D and SG&A going forward, you know, just to make sure you're, you're comfortably hitting that, that cash flow, target that you're interested in? And then maybe on the commercial side, you know, where do you still see the, areas to either drive breadth of Cosela in these, or depth at the individual, prescriber site that you have right now, to kind of, you know, boost numbers? Thank you. Yeah, thanks, Joe. Appreciate those. We'll have Raj hit the lerociclib question first, and then I'll have John hit R&D cuts, and Andrew can bring it home on the commercial question. Raj? Yeah. Hey, Joe. So we're conducting, or our investigator is conducting an investigator-sponsored study of trilaciclib in combination with lurbinectedin, and the updates that we're hearing from him are quite positive, not only in terms of the safety myeloprotection data, but also the antitumor efficacy data. So we'll look to ways to accelerate that, and then, you know, potentially follow that up with a, you know, a larger study that could be indication seeking. Hey, Joe, it's John. As far as OpEx reduction, do you recall we mentioned at the beginning of the year during our 10-K, 15%-20% reduction planned in 2024? We'll obviously provide an updated number for that at our earnings call and upcoming for Q2. But again, what we would look to as far as R&D costs, really what we have going forward after winding down this study is really just our post-marketing requirement study that's at least forecasted. Thanks, Joe. Yeah, I'll bring it in with the commercial side. So we continue to add in terms of breadth. We continue to add around 15 new accounts per quarter. That was what we reported for Q1, and we've continued to add new accounts in Q2. So there's significant opportunity for us to continue to add breadth, to keep growing in that $700 million market that Jack mentioned. In terms of depth, we're still at around 13% market share. We have about 20% market share in the top 100 stores. So again, there's a lot of opportunity for us to grow significantly just within the customer base that we've already built. So we believe there's ample opportunity for continued quarter-over-quarter growth, and we look forward to sharing our Q2 results soon. Great. Thank you very much. Our next question comes from the line of Ed White of HC Wainwright. Your line is open. Thank you. Good morning. I guess most of my questions were just asked, but maybe we can just talk a bit about the opportunity in small cell lung cancer. Can you delve a little bit more into initiatives to increase penetration in small cell lung cancer? And then also in the first quarter, you had mentioned that you had poor sales in the Southeast. I'm just wondering if there's any update there, if those issues have been addressed, and we can expect to see a more normalized return to growth in that area? Yeah, thanks. So in terms of commercial initiatives, so, you know, we continue to invest in our in-person sales presence, and, we've continued to invest in our strategic accounts presence as well. Those are our two major customer-facing initiatives. We've been promoting the real-world evidence data that really quite strongly supports our value proposition today in the extensive-stage small cell. We've also continued to invest in our digital efforts, which are really nice examples of closed-loop sales and marketing work there, where we're able to use email data, website data, and prescribing data to target our sales efforts in combination with digital. So across those initiatives, we've actually seen quite a lot of success and measurable success. In terms of that, slow start that we saw in Q1 with the Southeast, that was really based on, on a handful of accounts, large customers in the Southeast that were down, in the first part of Q1. Those customers actually, by the time we got into April, were growing double digits, so we feel like we were able to address, any of the performance issues in those accounts, really quite quickly and get them back into strong growth. So we're actually quite pleased with the performance we've seen from those accounts that, that started the year slow. Okay, great. Thanks for taking my questions. Thank you. And our next question comes from the line of Gil Blum from Needham & Company. Good morning, and, and thanks for taking our questions as well. Just a quick one. As it relates to continued development with Trodelvy, any additional thoughts there? Thank you. Yeah. Hey, hey, Gil. Yeah, no, we think there's there's really value in that ADC combination based on the data we, we showed at ASCO, where we had that approximately four month improvement in median overall survival and some subsets, that we saw even a greater improvement in overall survival. So that is certainly an area that we're continuing to explore and, you know, would develop further, with a partner. All right. Thanks for taking my question. Thank you. And our next question comes from the line of Laura Prendergast from Raymond James. Your line is now open. Hey, guys. Thanks for taking the questions. Sorry about the bad news today. I was just curious about the upfront and milestone payments related to Lerociclib, if you guys could provide any, you know, guidance on expectations for when you might see that hit the balance sheet. Yeah. Thanks, Laura. Appreciate it. Yeah, we've got quite a few, obviously, both with trilaciclib, potentially from some Simcere, and then other ones that are not trilaciclib-driven, which are more lerociclib-driven, both from Genor, if they get approval for their first indication, which we're expecting this year, a second indication that they've filed for that we're expecting at a future date. And then, of course, the recent partner announcement, which we believe has several, well, has several milestones associated with it, one likely this year and one likely front half of next year. So those are sort of the four or five milestone payments, four of which are not impacted whatsoever because they're lerociclib-related, one that is trilaciclib-related, which we'll see based upon what Simcere does moving forward. Great. Thank you very much. Thanks. Our next question comes from the line of Anupam Rama. Your line is now open. Hi, guys. This is Priyanka on for Anupam. Thanks for taking my question, and I just have a quick one. Does your updated cash guidance assume the initiation of an additional myeloprotection study? Yeah. Thanks for the question. At this point, as Raj mentioned, we've got one ISS underway that is covered in our cash runway, as is the PMR, which is more on the survival standpoint, but that one's already baked into our cost runway. So yes, those costs are already baked in. Just so, thank you so much for taking my question. Yep. I'm showing no further questions at this time. I would now like to turn the call back over to Jack Bailey. Yes. Thank you, operator, and thanks to everyone for joining us today. We'll look forward to speaking again soon at our Q2 earnings call in August. Thank you very much. Thank you for your participation in today's conference. This does conclude the program. You may now disconnect.
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