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spk06: Good day and thank you for standing by. Welcome to the G1 Therapeutics first quarter 2023 financial results conference call. At this time, all participants are in listen-only mode. After the presentation, there will be a question and answer session. To ask a question during the session, you will need to press star one one on your telephone. You will then hear an automated message confirming that your hand is raised. To withdraw your question, please press star 11 again. Please be advised that today's conference is being recorded. I would now like to hand over the conference to your speaker today, Will Roberts in Communications. Will, please go ahead.
spk05: Thank you, Mark. Good morning, everyone, and welcome to the G1 conference call to discuss our first quarter 2023 financial results and business update. The press release on these financial results was issued this morning. and can be found in a new section of our corporate website, g1350.com. On this morning call, the team will provide a business overview of the first quarter of 2023, including an update on our clinical programs and our commercial progress in that period with Costella, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in patients when administered prior to a platinum toposide-containing regimen or topotecan-containing regimen for extensive stage small cell lung cancer. As Mark mentioned, a Q&A session will follow the prepared remarks. Before we begin, I want 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 uncertainty 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, May 3, 2023. Joining me on the call today are Jack Bailey, our Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malek, our Chief Medical Officer, and John Umstead, our Chief Financial Officer. And with that, I'll turn the call over to Jack. Jack?
spk01: Thanks, Will. Good morning, everyone, and thank you for joining us on the call today. As you will hear from Andrew momentarily, our goal in the first quarter was to accelerate the Cosella volume growth we saw in the fourth quarter of 2022 by building the platform of deeply adopting customer organizations, and we executed on that goal. The team grew file volume by 21% over the prior quarter. Sales accelerated as well, growing 18% over the prior quarter, which is a meaningfully higher growth rate than we saw in Q4 of 2022. March was our highest volume month to date, and April was also one of our highest months. We have continued to learn and evolve our sales efforts. We are identifying the right combination of activities directed to the right accounts, primarily in community settings. In the first quarter of 2023, successful execution of these commercial initiatives and positive experiences with the drug led to increased penetration and improved results. reinforcing our confidence in achieving our sales guidance of 50 to 60 million in net sales in 2023, which we are reiterating today. Now, regarding the clinical pipeline, as Raj will discuss, we are executing on our ongoing clinical trials with near-term data readouts, in particular, our two Phase II studies and our Phase III in triple negative breast cancer. Updated data are being presented from those two Phase IIs later this quarter, and the interim OS analysis for the TMBC Phase III is now expected to occur in the first quarter of 2024. And as mentioned on our last call, we are conducting our business in a manner that is mindful of our cash and expenses, with the goal of extending our cash runway through all of our clinical readouts. To that end, we announced this morning that we have proactively strengthened our balance sheet even further in a manner that is non-equity diluted to our shareholders by monetizing all future royalties and milestones from CIMCIR. This brings us $30 million now and up to $48 million in total. This transaction has allowed us to extend our cash runway further into 2024 and beyond each of these data readouts. As a reminder, we retain the rights to try the cyclips throughout the rest of the world. Now we'll take these in order Andrew will first cover our recent commercial efforts since the start of the first quarter of 2023. Raj will reiterate the timing of upcoming data readouts. And finally, John will provide the financial results for the quarter and remind you of our revenue, expense, and cash guidance and discuss the addition to our cash reserves. Then I'll be back for some concluding comments. With that, I will now turn the call over to Andrew.
spk11: Thank you, Jack. I'm glad to be with you today to provide an update on our first quarter 2023 sales performance and the progress we've made in our commercial execution over recent months. Our goal in the first quarter was to accelerate the volume growth we saw in the fourth quarter of 2022 by building a broader platform of more deeply adopting customer organizations. We delivered on this goal in Q1, and I'll discuss some of the factors underlying our performance today. Beginning with sales results, we ended the quarter with $10.5 million in net sales in Priscilla, representing 21% vile volume growth compared with Q4. This has been our strongest period of growth since Q2 of last year. Volume growth compared with the first quarter in 2022 was 103%, demonstrating our continued ability to generate growth year over year. Average vial volumes per day grew each month in the quarter, with the strongest growth being in March, which was our highest month launched to date. All three of our regions experienced double-digit quarter-over-quarter growth, and two-thirds of our territories grew in the quarter. As we've previously stated, in the extensive-stage small-cell lung cancer market, our quarterly growth is highly reliant on gaining new patients, either from new accounts or from existing accounts, in order to compensate for patients who complete their chemotherapy regimen and drop off therapy. In the first quarter, we brought on board 95 new accounts, which was roughly similar to the fourth quarter of 2022. March was our best month on record for new accounts with over 40 added. Many of these new accounts are affiliated with larger parent organizations, and we added three new top 100 organizations in Q1, giving a total of 72 of the top 100 which have ordered Costello launch to date. In Q1, 54 top 100 and 200 organizations in total had orders, which is our broadest set of ordering customers launched today. Our reorder rate remains high, and over 80% of ordering customers reordered within the quarter. Going forward, although new top 100 customers remain a focus, consistent and deep ordering from large customers is more important for sustained growth. With regard to improving depth of adoption, We had 17 organizations in Q4, which ordered more than 100 vials per quarter, and 19 in Q1. In Q1, our top five customers ordered 20% of total volume in the period, which is similar to what we saw in Q4, although there was some change in the organizations which composed the top five as some began to adopt more deeply. Our focus in community oncology includes working with customers to understand optimal placement of Coachella in their EMR. In Q1 2023, customers who elected to place Cosella in a default position as their standard of care demonstrate roughly four times the depth of utilization compared with customers who simply list Cosella as an option. Also among those organizations which adopted more deeply were those who engaged in our volume-based contract agreements. Volumes in our contracted customers increased 50% during the quarter. By the end of Q1, roughly 15% of our business was with customers who have a volume agreement, and we have several new agreements now active in Q2 where we see potential for deeper adoption. Our estimate of CoSELLA patient share continues to grow, and although claims data for Q1 are not fully available, we estimate patient share in the 9% to 10% range in the first-line market, which represents the majority of our use. We saw 78% of volume in the quarter come through community clinics and hospitals and 22% of volume from academic centers. 98% of our volume in the quarter was in commercial supply, with 2% provided through our patient assistance program. Our payer mix remains stable, with the majority covered by Medicare, and third-party payer reimbursement has remained strong. Moving into Q2 2023, April has also been one of our highest volume months, although as always, volumes can vary month to month due to the limited duration of chemotherapy in small cell lung cancer. Our execution continues to focus on large community oncology customers, and we're seeing the benefits of the strategic shifts we've made over the last two quarters. We will continue to evolve our commercial model as necessary to achieve our ambitions for Cosella. With that, I'll turn the call over to Raj.
spk08: Thanks, Andrew, and good morning. I'll provide an update on the important data readouts coming over the next few quarters and the exciting data expected early next year. Updated results from our combination trial with the ADC-Sacituzumab have been accepted for poster presentation during the ESMO Breast Cancer Conference on May 12th. These data follow the promising initial safety and myeloprotection results from the first 18 patients that showed a clinically meaningful on-target effect of Trilocycline to reduce the rates of multiple adverse events compared to Sacituzumab single-agent data from the ASCENT trial. This presentation will also include initial efficacy results, including outcome by tumor PD-L1 status, a topic I'll discuss further in a moment. The most important data from this trial will be the overall survival endpoints, which we expect to reach in the first quarter of 2024. Similarly, updated results from our mechanism of action trial in neoadjuvant TMBC have been accepted for presentation at the ASCO meeting on June 4th. Initial data presented last year showed favorable alterations in the tumor microenvironment following a single dose of trilocyclic monotherapy with a trend towards an increased CD8-positive T cell to Treg ratio, demonstrating the immunomodulatory effects of trilocyclic. The ASCO data will include tumor pathological complete response and potential correlations with molecular analyses of tumor at baseline and following a single dose of trilocyclic evaluating changes in immune-related gene signatures, including those related to T-cell memory. Pathological complete response results will also include outcome by tumor PD-L1 status. Next, we expect to provide additional safety and efficacy results, including preliminary progression-free survival results from Preserve3 in bladder cancer in the middle of this year. We'll then look forward to the important overall survival endpoints which we expect to reach in the first quarter of 2024. Finally, following a recent evaluation of blinded events, we now estimate that the interim overall survival analysis of the pivotal TMBC trial will occur in the first quarter of 2024. As a reminder, this trial is based on the foundational data from our Phase II trial that showed a statistically significant overall survival advantage for patients enrolled in both trilocyclic arms compared to placebo, with hazard ratios of 0.31 and 0.4, respectively. If the trial meets the interim analysis stopping rule, it will terminate, and G1 will report the top-line results. If it does not, the trial will continue to the final analysis. As we approach these data, including the Phase IIs, over the coming months, it's important to keep in mind what we have learned from prior studies, including the Phase II TMBC trial, namely that Trilocyclic appears to have the greatest effect on longer-term endpoints, like overall survival, rather than earlier efficacy measures such as response rate and progression-free survival. This is consistent with other immunotherapies like checkpoint inhibitors as well, which have the greatest effect at survival endpoints. Our data to date suggests that this could be due to trilocyclic, enhancing long-term immune surveillance, and increased generation of certain memory T-cells. Additionally, PD-L1 status of the tumors is likely to affect how trilocyclic works across these different measures of efficacy, including how long it may take to see any potential benefit. For example, in patients with PD-L1 positive tumor, which usually have an immune-inflamed tumor microenvironment, we observed a numerical improvement in earlier efficacy metrics, including overall response and progression-free survival. Additionally, the capillary microbes for overall survival separated early and continued to improve over time. This led to a median overall survival of 32 points. of 32.7 months for patients receiving Trelacyclib compared to 10.5 months for patients receiving chemotherapy alone, with a hazard ratio of 0.34. On the other hand, in patients with PD-L1 negative tumors, which tend to have immune-excluded or immune-desert tumor microenvironments, we did not observe a meaningful improvement in response rate or PFS. However, we did observe an improvement in median OS of 17.8 months for patients receiving trilocyclic, compared to 13.9 months for patients receiving chemotherapy alone. More interestingly, the Kaplan-Meier curves for overall survival did not separate until about 15 months, but this separation then continued to accelerate over time, leading to a hazard ratio of 0.48, which is a very robust result. result in these patients with PD-L1 negative tumors, excuse me. So while we will watch the early measures of response in PFS that we'll present in the coming months, we're most interested in following these patients for overall survival to evaluate whether Trilocyclic can meaningfully improve patient outcomes in these particular settings. As I mentioned, we currently anticipate that we will reach the overall survival endpoints for the ADC and bladder phase two studies in the first quarter of 2024. This is approximately the same time we expect to see the interim OS analysis for our pivotal first-line TMBC trial, so early next year will certainly be an exciting time for us. With that, I'll turn the call over to John for a review of the financial results.
spk10: Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the first quarter of 2023 are available in this morning's press release and will be in the 10Q, which we expect to file today after market close. Our total revenue for the first quarter of 2023 was $12.9 million, comprised of net Cosella revenue of $10.5 million and license revenue of $2.5 million. The license revenue from the current quarter is related to supply and manufacturing services with Sincere, royalty revenue from Sincere, and clinical trial reimbursements from EQRX and Sincere. For the same period in 2022, total revenue was $6.9 million, including $5.5 million of net product revenue. Cost of goods sold for the three months ended March 31, 2023, was $1.5 million, compared to $700,000 for the same period in 2022. Our research and development expenses for the first quarter of 2023 were $15.5 million compared to $26.3 million for the first quarter of 2022. The period-over-period decrease in R&D expenses was primarily due to reduced clinical trial costs. Our selling, general, and administrative expenses for the first quarter of 2023 were $21.8 million compared to $26.7 million for the first quarter of 2022. Comparing the two periods, the decrease in SG&A expenses was primarily due to decreases in commercialization activities, personnel costs, and professional fees. As we mentioned on the last call, while we expect our 2023 operating expenses to be 20% to 30% lower than that of 2022, we didn't see the impact in the first quarter due to severance and costs associated with winding down Preserve 1. But we'll start to see these savings in the current quarter with most of it occurring in the second half of the year. Regarding our cash position, we ended the first quarter with cash, cash equivalents, and liquid securities of $116.3 million compared to $145.1 million as of December 31st, 2022. While on the topic of our cash position, as Jack mentioned at the start, we announced this morning that we strengthened our balance sheet even further without issuing additional equity by monetizing the future royalties and milestones from Sincere, which brings us $30 million as of the current quarter and up to $48 million in total. The additional $18 million are pending positive data from our ongoing pivotal TNBC Phase III trial. Specifically, G1 would receive an additional $5 million on filing of an NDA in China and an additional $13 million on approval in China. All other aspects of the strategic collaboration remain in place, including data sharing and participation and cost sharing in global clinical trials of Trilocyclo. As a result of this transaction, we are now able to extend our cash runway even further into 2024, beyond the readouts of our clinical trials that Raj discussed earlier. And as a reminder, Greater China was the only partner in geography. As such, we retain the rights to develop and commercialize trial recycling throughout the rest of the world. Finally, regarding revenue and cash runway guidance for 2023. Today, we reiterated our net product revenue guidance for 2023 of a range between $50 million and $60 million. We conservatively estimate our 2023 gross net expense percentage to be in the low to mid-20s, primarily due to the potential impact of the wastage provision of the 2021 infrastructure bill. As a result of our revenue, expense, and cash guidance, we anticipate a year-end cash, cash equivalents, and marketable securities balance of approximately $70 to $80 million before taking into account the impact of the sincere monetization I discussed earlier. With that, I'll turn the call back over to Jack for some closing comments. Jack.
spk01: Thank you, John, Raj, Andrew, and Will. And as always, I want to thank the people living with cancer for your inspiration. You drive us toward our goals every day. Now, as you heard from Andrew, we remain confident in the potential of Coachella in lung cancer and are making good progress and driving real results. During the first quarter, we grew vial volume by 21% and net product sales line by 18% over the prior quarter. We brought on board 95 new accounts. March was our best month on record. for both vials and new accounts. Regarding depth, we had 19 organizations that ordered more than 100 vials during the quarter compared to 17 in the fourth quarter. And volumes in our contracted customers increased 50%. Given this, we have reiterated our Cosella Net Sales Guidance of between $50 and $60 million for 2023. Beyond the sales line, We expect to present additional results from both of our ongoing Phase II TMBC trials, including by tumor PD-L1 status, later this quarter, followed by additional data from the bladder cancer Phase II trial mid-year. And as you heard from Raj, we now expect the interim OS analysis for the pivotal Phase III TMBC trial will occur in the first quarter of 2024. Finally, we have added additional near-term capital to extend our cash runway even further beyond the important clinical trial readouts expected in early 2024. We are one of the very few companies in our sector that not only have a late-stage pipeline with pivotal data expected in less than 12 months, but also have an approved product that is novel, important, and growing. which, assuming we hit our internal forecast, should drive us to cash flow positivity in the next few years. Thank you for your time this morning. We will speak again in this format on the second quarter 2023 call in August, and we'll have a variety of opportunities to communicate the upcoming results from our Phase II trials throughout the year. With that, I'll close the call, turn it over to Q&A. Operator, would you please remind our listeners how to ask a question?
spk06: Thank you. At this time, we will conduct the question and answer session. As a reminder, to ask a question, please press star 1 1 on your telephone and wait for your name to be announced. To withdraw your question, please press star 1 1 again. Now, please stand by while we go ahead and compile our Q&A roster. And thank you for waiting. Our first question will be from Gil Bloom of Needham and Company. Go ahead, Gil.
spk02: Good morning, everyone, and congratulations on continued execution here. So maybe one, because I don't know if I heard this very well. How many centers went on EMR adjustments, meaning centers that could have it as a default? I just missed that.
spk11: Yeah, thanks, Gil. So at this point, roughly around a dozen of our organization customers have COSELLA as the standard of care default selection in their EMR. And one of the executional strategies we have is to continue to work with organizations to educate them about how they can do that for themselves. So we're excited about the potential that that offers, and we see that as a great growth strategy moving forward.
spk02: Thank you for the clarification. And Raj, maybe a couple for you here. So we're looking for the Trudelvi data on May 12th at a poster, and it's interesting. I mean, you've been carefully guiding that the more important readout is going to be at OS, but what can we learn at this interim, and what could be further steps?
spk08: Yeah, here you go. So the data that we'll present will be the updated safety data. Sorry, I've got a bad cold or something today. As well as response rate and early PFS data. But the important point is really the OS data. And the reason for that is, as I mentioned, just the effect on long-term immune surveillance, which we believe is through generation of more memory T cells. But we will present the response rate and PFS data that we have. That should be considered immature at this stage as well.
spk02: And kind of a very similar topic, you will be presenting PFS data from the bladder cancer study, assuming, you know, on the positive end here that you see some separation of curves there. I mean, that's a possibility, and it should reflect on future OS fitness. Okay, I look forward to hearing more at the beginning of next year. Sounds like you're going to have a pretty busy first quarter. Thank you.
spk05: Yep.
spk06: And thank you. Please wait while we bring our next question up. And our next question will come from Ed White, HC Wainwright. Good morning.
spk03: Thanks for taking my question. So last quarter, you mentioned that patients were on drugs for roughly 3.3 to 3.5 cycles. I'm just wondering if that number is holding and if there's anything that can be done to increase that duration. And then also, how should we be thinking about the length of time patients will be on drugs in triple negative breast cancer once that indication is approved?
spk11: Hi, thanks for the question. Yeah, so the standard for first-line patients undergoing chemotherapy is four cycles, and they're 21-day cycles, so it's an 84-day duration of therapy. So on average, we see, and it always hovers between, I would say, about 3.2 to 3.4 or 5 on average out of the four. really in the last couple of quarters. In terms of extending that closer to the four, I think we have to remember that sometimes as a growing product and with bringing on board new accounts, often the first experience that a new account has is actually a patient in the second or third cycle who already has reached a point where they've discovered that existing standards of care no longer apply or help that patient. So I would expect as we continue to bring on board new accounts that that number will hover between the three and 3.5. In terms of expanding duration, so obviously TOPS-TCAN patients do extend further because their regimen is different and they can go on indefinitely, but that's a smaller patient population for us. And then moving into triple negative breast cancer, again, obviously the treatment there is the progression. We would expect a longer duration of therapy in that circumstance. It could be 10 to 20 cycles of a potential in triple negative breast cancer. So that's a very exciting thing. proposition to be able to build a larger market presence and more duration of therapy.
spk03: Great. Thanks, Andrew. And just a housekeeping question. You mentioned that gross to net for the year is expected to be in the mid-20s. What was it in the first quarter?
spk10: It was just under 21% for the first quarter.
spk03: Okay. And then my last question is just regarding the sincere payments with the 18 million left, the five, and then the 13 on approval. You know, not being as familiar with the Chinese regulatory agency as I am with the U.S., can you give us any guidance on the timing of when you expect to receive those two payments?
spk01: Yeah, Ed, this is Jack. I would, you know, use somewhere around one quarter delay from the U.S., so it usually takes them two to three months to be able to, you know, get all the requisite data and submit it, but you're only talking about a quarter delay from us, so when you see our filing date, adding a quarter would be safe, and you can expect that in the Chinese market.
spk03: Great. Thanks, Jack. Thanks for taking my question.
spk01: Thanks, Ed.
spk06: Thank you. Please stand by while we bring up our next question. Our next question will come from Dane Leon of Raymond James.
spk09: Thank you for taking the questions and congrats on the execution with the Casella commercial trajectory. Two questions for me, maybe first one for Jack. Thinking about the Casella, the current Casella commercial trajectory, and the current OpEx burn, what, you know, if we obviously assume, you know, the bulk of R&D are from the ongoing studies that you discussed today, take that into account, how much SG&A could be rationalized to theoretically hit a positive EBIT margin on the current Satella commercial trajectory or where that break-even point would theoretically be And then secondly, maybe for, well, I guess maybe for you, Jack, again, strategically with Preserve3 and bladder cancer, the primary endpoint of this study is PFS. I think Raj was talking about OS or something like that. But the reality seems to be if you have an equivalent outcome in the second quarter here, on PFS to the standard of care arm, but you have an advantage in terms of myeloprotective effects, could you actually file on that for a label expansion with this study? You know, the reason I ask that is kind of twofold. One, because that's, you know, kind of the label on myeloprotection versus primary outcomes. But secondly, with the EV302 study you're reading out before the end of the year and likely going to be positive, even if you had some hint of a PFS advantage that then becomes debatable within the question of what happens with different frontline residents. So what's a smart move just to see if you could file on the frontline chemo standard of care under a myeloprotective effect now versus wait and then have to manage the complexity of maybe a shift in frontline care? Thank you.
spk01: Yeah, thanks, Dan. I'll tackle the first one and then flip it over to Raj for the second one. I think when you look at the actions we've taken in terms of reducing our burn and the trajectory of sales, we're, as we mentioned, sort of, I would say, two years from being cash flow positive and having profitability in our site. So, you know, give or take a quarter, obviously, it'll largely depend on the sales trajectory more than anything else, but we're always going to look to manage our expense base as tightly as possible. But on the second question, I'll flip it over to Raj.
spk08: Yeah, so Dane, you know, I think this study, as you said, PFS is the primary. The important point just to mention on PFS and rationale for doing the study was looking at how trialer combines with a value map, you know, to evaluate the, you know, that IO enhancing effect of trialer. Regarding myelo, a couple of points there. I think to recall that this is a gemcitabine-containing regimen, and we have not seen any myelo effects with TMBC. So we think it's unlikely that we'll see that with the bladder regimen. However, it depends on what the data are, and then depending on the strength of the data, of course, we could have discussions with the agency. But just to set the expectations based on what we saw previously in TMBC, We think it's a low likelihood that the study would show a myelo benefit, but we'll still see what the data show.
spk12: Okay, thank you.
spk06: Thank you. Please stand by while we bring up our next question. Our next question will come from Troy Langford with TD Cowan.
spk07: Hi, everyone. Thanks for taking our questions and congrats on all the progress this quarter. We just have two quick ones, one commercial one, and then I have a follow-up for Raj after that. So just quickly on Casella, given the Casella members for the quarter, just how do you all think or how do you all expect the sales trajectory to reflect over the course of the year? And what else do you all think you need to do in order to hit your internal expectations for the full year of 2023 Casella sales?
spk11: Yeah, thanks. So, yeah, as we said before, month-to-month can be a little bit choppy. So, you know, we may see some ups and downs on a month-to-month basis. We do predict ongoing growth through the year to hit that guidance, though, based on what we've seen. And I think, you know, the new accounts we added in March is a good testament to the level of demand that there is still out there for the product. And it's obviously a good way to enter a new quarter with a number of new accounts. So, So we feel like we've got the right executional strategy to continue to fuel growth going forward. And, you know, I don't think it needs to be too complicated in terms of what we need to do to inflect growth. It is building physician and provider champions at the account level. It's making sure that we can systematize COSELLA because expensive space small cell is still a relatively rare tumor type. So the more reminders we have in the system and ideally leading to that EMR optimal placement helps make sure to be able to help patients. And then, of course, these volume-based contracts really do a very similar thing, which is systemize the uptake of the product at an organizational level. If we get those things right, we'll see more and more deeply adulting organizations, which ultimately allows us to generate that overall in the market and will certainly give us the opportunity to hit those targets that we've set.
spk07: Okay, great. And then just a clinical one for Raj. What I guess in terms of the Phase II combination data with Tredelvi, can you just remind us what you would need to see from that study in order to feel more confident in the decision to move forward in a pivotal study?
spk08: Yeah, so as I mentioned, Troy, it's really the overall survival data that we'll be looking at, which will be first quarter of next year. You know, for the data, as we'll grasp, You know, what I would be looking at is what is our patient population compared to us then? For example, we had many more patients who had prior checkpoints compared to that study. So evaluating the response rate and the early PFS data in that context, as well as the safety. But really, it's the overall survival that we're most interested in looking at early next year, the first quarter.
spk07: Great. Thanks, guys.
spk06: Thank you. Please stand by for the next question. Our next question will be from Anupam Rama with J.P. Morgan.
spk00: Hi, guys. This is Priyanka on for Anupam. Can you provide more granularity on the cash or cash runway in regards to the sincere agreements?
spk10: Yes Priyanka, thanks. This is John. Yes, so with the inflow of cash 30 million that we mentioned, this will continue to allow us to get through the trial readouts that Raj mentioned in the first half of 2024 and continuing on in the year.
spk00: Gotcha, thanks.
spk06: Thank you. Please wait a moment while we bring up our next question. Our next question will be from David Neardarten with Webb Bush Securities. Go ahead, David.
spk12: Hey, thanks for taking the question. I had a follow-up just thinking about the different toxins involved with the ADC versus the chemo and triple negative breast cancer. I mean, yeah, just going back to the read-through, is that important to think about, you know, if there's any read-through from... the combo with Tredelvi versus, you know, the chemo backbone next year in Q1? Or, you know, is there, you know, any other data points, you know, we can, you know, extract from the upcoming data that would help, you know, give people confidence in the gen, you know, backbone for Q1 next year?
spk08: So, David, just so I understand, are you asking specifically for the ADC study or read through to the TMBC study, just so I'm understanding your question?
spk12: Yeah, yeah. It's like, is there, I mean, well, it's maybe a more basic question. Like, can we read anything through from a study with a different, you know, drug partner with a different mechanism of action to, you know, to another study that has, you know, two different chemo partners that, you know, have a different mechanism of action. Is that, are we, sorry to say it, but are we like wasting brain cells here trying to think about that? And should we just look at the trials in isolation from each other? Thanks.
spk08: Yeah, no, that's a good question. I think the strongest read through to the TMBC phase three is the phase two data, right? Okay. Which is the same doublet gemcarbo And so, you know, where we saw the very strong effect. So I think, to your point, the ADC trial will be an additional important piece of information, obviously, but in terms of the phase three TMBC trial, it's really the phase two TMBC trial with Gemcargo that provides the strongest, you know, evidence for what we may expect in that phase three. Okay.
spk12: I just wanted to triple check on that. Thanks, guys.
spk06: Thanks, David. Thank you. Please stand by for our next question. And our next question will come from Kaveri Pullman with BTIG. Go ahead.
spk04: Hey, good morning, everyone. This is Christian, an associate here at BTIG. I'll be asking questions for Kaveri today. So, the first question is, I assume you have some theories on your drug interacting with chemo in a negative way. If you go back to your preclinical data, are there any models where, in retrospect, kind of predictive that might be useful in finding combinations for the future?
spk08: So, hi, this is Raj. So, are you referring specifically to the colorectal study here in terms of when you refer to a negative way? We certainly have not seen that in small cell in TMBC where we showed an improvement in survival, just so I understand your question.
spk04: Yeah, colorectal cancer.
spk08: Yeah, so there we're actually doing a number of investigations currently. And so, you know, when we have those data, we'll obviously release them. But, you know, that's certainly one of our hypotheses. is was there an unexpected interaction with 5-FU that potentially resulted in the effect we saw?
spk04: Oh, okay. That actually kind of brings me to my next question, which is that there have been some studies suggesting an antagonistic effect of giving CDK4-6 inhibitors with chemo. And I was wondering if you saw anything like that with your preclinical models, And for CRC, where 5-FU is used, how clear is the regimen that suggests that using Trilocyclib before chemo is the best way to see the benefit versus with chemo or a little later after chemo?
spk08: Yeah, so specifically for preclinical work, I mean, we had done work with 5-FU in combination actually with a checkpoint inhibitor plus Trila, which showed an improvement in efficacy. And we, of course, had lots of data with 5FU showing that myeloprotection benefit. So again, there was certainly no data preclinically to suggest that we would see what we saw in colorectal. And we also did that work with other chemotherapies as well. But we're definitely expanding our work with looking at different chemotherapies now, given this data, to better understand it.
spk04: Okay. Thank you so much for providing that clarity.
spk06: Thank you, everyone, for your questions. I will now turn it back to Jack Bailey, CEO, for closing remarks.
spk01: Thank you, Operator. As always, we look forward to keeping everyone updated as we progress. Thank you for joining us on the call today. We'll speak again soon.
spk06: Thank you everybody for your participation. This now concludes today's conference call. You may disconnect.
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