G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2023 Earnings Call Transcript

G1 Therapeutics, Inc. (NASDAQ:GTHX) Q1 2023 Earnings Call Transcript May 3, 2023

Operator: Good day and thank you for standing by. Welcome to the G1 Therapeutics First Quarter 2023 Financial Results Conference Call. 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.

Will Roberts: 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 News section of our corporate website, g1therapeutics.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 COSELA, which is approved and commercially available to decrease the incidence of chemotherapy-induced myelosuppression in patients who administered prior to a platinum/etoposide-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, Chief Executive Officer, Andrew Perry, our Chief Commercial Officer, Raj Malik, our Chief Medical Officer, and John Umstead, our Chief Financial Officer.

And with that, I will turn the call over to Jack. Jack?

Jack Bailey: 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 COSELA 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 vial 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 lead to increased penetration and improved results, reinforcing our confidence in achieving our sales guidance of $50 million 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 2 studies and our Phase 3 in triple-negative breast cancer. Updated data are being presented from those Phase 2s later this quarter and the interim OF analysis for the TNBC Phase 3 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 Simcere. 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 trilaciclib throughout the rest of the world. Now, we will 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 will be back for some concluding comments. With that, I will now turn the call over to Andrew.

Andrew Perry: Thank you, Jack. I am glad to be with you today to provide an update on our first quarter 2023 sales performance and the progress we have 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 will discuss some of the factors underlying our performance today. Beginning with sales results, we ended the quarter with $10.5 million in net sales of COSELA, representing 21% vial 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 launch-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 have previously stated in the expansive-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 I have ordered COSELA launch to-date. In Q1, 54 of top 100 and 200 organizations in total had orders, which is our broadest set of ordering customers launch to-date. Our reorder rate remained high and over 80% of ordering customers reordered within the quarter. Going forward although a new top 100 customers remain a focus, consistent and deep ordering from large customers is more important for sustained growth. With regard to 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 COSELA and their EMR. In Q1 2023, customers who elected to place COSELA in a default position of their standard of care demonstrate roughly 4x the best of utilization compared with customers who simply left COSELA as an option. Also among those organizations, which is also more deeply for 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 active in Q2, where we see potential for deeper adoption.

Our estimate of COSELA patients 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 assessments program. Our payer mix remained stable with the majority covered by Medicare and third-party 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 and small cell lung cancer.

Our execution continues to focus on large community oncology customers and we are seeing the benefits of the strategic shifts we have made over the last two quarters. We will continue to evolve our commercial model as necessary to achieve our ambitions for COSELA. With that, I will turn the call over to Raj.

Raj Malik: Thanks, Andrew and good morning. I will 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 12. These data follow the promising initial safety and myeloprotection results from the first 18 patients that showed a clinically meaningful on target effect of trilaciclib 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 will 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 4. Initial data presented last year showed favorable alterations in the tumor microenvironment following the single dose of trilaciclib monotherapy with a trend towards an increase CD8 positive T-cell to T-reg ratio demonstrating the immunomodulatory effects of trilaciclib. The ASCO data will include tumor pathological complete response, and potential correlations with molecular analyses of tumor at baseline and following the single dose of trilaciclib. Evaluating changes in immune related gene signatures including those related to T-cell memory, pathological complete response results, but 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 PRESERVE 3 in bladder cancer in the middle of this year. We will 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 or the pivotal TNBC trial and occur the first quarter of 2024. As a reminder, this trial is based on the foundational data from our Phase 2 trial that showed a statistically significant overall survival advantage for patients enrolled in both trilaciclib arms compared to placebo, but 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 2s over the coming months, it’s important to keep in mind what we have learned from prior studies including the Phase 2 TNBC trial, namely that trilaciclib appears to have a 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 trilaciclib and as a long-term immune surveillance and increased generation of certain memory T-cells.

Additionally, PD-L1 status of the tumors is likely to affect how trilaciclib that 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 tumors, 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 Kaplan Meier curves overall survival separated early and continued to improve over time. This led to a median overall survival of 32.7 months for patients receiving trilaciclib 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 trilaciclib, compared to 13.9 months for patients receiving chemotherapy alone. More interestingly, 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 in these patients with PD-L1 negative tumors, excuse me. So while we will watch the early measures of response and PFS that will present in the coming months, we are most interested in following these patients for overall survival to evaluate whether trilaciclib 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 2 studies in the first quarter of 2024.

This is approximately the same time we expect to see the interim OS analysis for pivotal first line TNBC trial. So early next year, will certainly be an exciting time for us. With that, I will turn the call over to John, for a review of the financial results.

John Umstead : Thanks, Raj and good morning, everyone. As Will, mentioned full financial results from the first quarter 2023 are available in this morning’s press release and will be in the 10-Q, which we expect about today after market closed. Our total revenue for the first quarter of 2023 was $12.9 million, comprised of net COSELA revenue of $10.5 million and licensed revenue of $2.5 million. The license revenue from the current quarter is related to supply and manufacturing services with Simcere, royalty revenue from Simcere and clinical trial reimbursements from EQRx and Simcere. 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 3-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 reduce 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 will start to see the 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 31, 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 Simcere 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 3 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 on trilaciclib. 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 geography. As such, we retain the rise to develop and commercialize trilaciclib 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 to 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 yearend cash, cash equivalents and marketable securities balance of approximately $70 million 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 Jack for some closing comments.

Jack Bailey: Thank you, John, Raj, Andrew and Will. And as always, I want to thank the people living with cancer for your inspiration to drive us toward our goals every day. Now, as you heard from Andrew, we remain confident in the potential of COSELA 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 onboard 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 COSELA net sales guidance of between $50 million and $69 million for 2023.

Beyond the sales line, we expect to present additional results from both of our ongoing Phase 2 TNBC trials, including by tumor PD-L1 status later this quarter followed by additional data from the bladder cancer Phase 2 trial mid-year. And as you heard from Raj, we now expect the interim OS analysis for the pivotal Phase 3 TNBC 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 late-stage pipeline with pivotal data expected in less than 12 months, but also have an improved product that is novel important and growing, which assuming we hit our internal forecasts 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 of 2023 calls in August. And we will have a variety of opportunities to communicate the upcoming results from our Phase 2 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?

Q&A Session

Operator: Thank you. Our first question will be from Gil Blum of Needham & Company. Go ahead, Gil.

Gil Blum: 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 since expected hazard as a default. I just missed that.

Jack Bailey: Yes, thanks, Gil. So, at this point, roughly around 1,000 of our organization customers have COSELA 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 to they can do that for themselves. So we’re excited about the potential that offers and we see that as a great growth strategy moving forward.

Gil Blum: Thank you for the clarification. And Raj maybe a couple for you here, so we are looking for the data on May 12 at a poster. And it’s interesting, I mean, you’ve been carefully guiding more important readouts in the OS, but what can we learn at this interim and what could be further steps?

Raj Malik: Yes. Hey, Gil. So the data that will present will be the updated safety data. Sorry, I have got some. That I have got cold or something today, but as well as response rate and early PFS data, but the important point is really that 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 or more memory T-cells. So – but we will present the response rate and PFS data that we have that should be considered immature at this stage as well.

Gil Blum: And kind of a very similar topic, you will be presenting PFS data in the bladder cancer study assuming on the positive and here that you see some separation of curves there. I mean, that’s a possibility and it should reflect on future OS, couldn’t it?

Raj Malik: That is correct. That is correct.

Gil Blum: Okay, I look forward to hearing more at the end of – at the beginning of next year. Sounds like you’re going to have a pretty busy first quarter. Thank you.

Jack Bailey: Yes.

Operator: And our next question will come from Ed White, H.C. Wainwright.

Ed White: Good morning, 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 drug in triple negative breast cancer once that indication is approved?

Andrew Perry: Yes, thanks for the question. Yes, so the standard for first line patients undergoing chemotherapy is four cycles, 21-day cycle. So it’s 84-day duration of therapy. So, on average, we see – and it always hovers between let’s say about 3.2 to 3.4 or 5 on average as it before really in the last couple of quarters. In terms of extending that closer to the four, I think we have to remember that sometimes it’s a growing product. And with bringing onboard new accounts, often the first experience that new account has is actually a patient in the second or third cycle who already has reached a point where they have discovered that existing standards of care no longer apply or held that patient. So I would expect as we continue to bring onboard new accounts that number will hover between the 3 and 3.5. In terms of extended duration, so obviously, the topotecan 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 as a potential and triple negative breast cancer. So that’s a very exciting proposition to be able to build out a larger market presence and more duration of therapy.

Ed White: 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?

John Umstead: It was just under 21% for the first quarter.

Ed White: Okay. And then my last question is just regarding the Simcere payments with the $18 million left, the $5 million and then the $13 million on approval, nothing as familiar with the Chinese regulatory agency with the U.S. Can you give us any guidance on the timing of when you expect to receive those two payments?

Jack Bailey: Yes. This is Jack. I would use somewhere around one quarter delay from the U.S. So, usually it takes two months to three months to be able to get all the requisite data and submit it, but you are 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.

Ed White: Great. Thanks Jack. Thanks for taking my questions.

Jack Bailey: Thanks Ed.

Operator: Thank you. Please stand-by while we bring up our next question. Our next question will come from Dane Leone of Raymond James.

Dane Leone: Thank you for taking the questions and congrats on the execution with COSELA commercial trajectory. Two questions for me, maybe first one for Jack. You are thinking about the current COSELA commercial trajectory and the current OpEx burn. What if we obviously assume the bulk of R&D or 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 COSELA commercial trajectory or where that breakeven point would theoretically be? And then secondly, maybe for I guess, maybe for you Jack, again, strategically with PRESERVE 3 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 the PFS to the standard of care arm, but you have an advantage in terms of my protective effects, could you actually file on that for label expansion with this study? The reason I asked that is kind of twofold. One, because that’s kind of the label on myeloprotection versus primary outcomes. But secondly, what the EB-302 study you are 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 that then becomes debatable, within the question of what happens with different frontline regimen. So, what the smart move just to see if you could file on the frontline chemo standard of care under a mile of protective effect now versus weight, and then have to manage the complexity of maybe a shift in frontline care?

Thank you.

Jack Bailey: Yes. Thanks Dane. I will tackle the first one and then flip it over to Raj for the second one. I think when you look at the actions we have taken in terms of reducing our burn, and the trajectory of sales were, as we mentioned, sort of, I would say 2 years from being cash flow positive, and having profitability in our site. So, give or take a quarter, obviously it will largely depend on the sales trajectory more than anything else, but we are always going to look to manage our expense base as tightly as possible. But on the second question, I will flip it over to Raj.

Raj Malik: Yes. So, Dane, I think this study is, as you said, PFS is the primary, important point just to mention on PFS, and rationale for doing the study was looking at how trials are combined to the avelumab to evaluate the IO enhancing effect on trial. Regarding myelo, a couple of points there, I think to recall that this is a jump side of being containing regimen. And we have not seen any myelo effects with TNBC. So, we think it’s unlikely that we will see that with the bladder regimen. However, it depends on what we selected in that. 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 TNBC. We think it’s a low likelihood that the study would show myelo benefit. But let’s just see what the data shows.

Dane Leone: Okay. Thank you.

Operator: Thank you. Please stand-by while we bring up our next question. Our next question will come from Troy Langford with TD Cowen.

Troy Langford: Hi, everyone. Thanks for taking 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 like COSELA, given the customer numbers for the quarter, just how you all think or how you all expect the sales trajectory to inflect over the course of the year? And what else do you think you hope like you need to do in order to hit your internal expectations for the full year 2023 COSELA sales?

Jack Bailey: Yes. Thanks. So, as we have said before, month-to-month can be a little bit choppy, so we may see some ups and downs on a month-to-month basis. We do present the ongoing growth through the years ahead that guidance. So, based on what we have seen, and I think the new accounts we added in March is a good testament for the level of demand that there is that was there for the product. And it’s obviously a good way to enter a new market with a number of new accounts. So, we feel like we have got the right executional strategy to continue to fuel growth going forward. And I don’t think it needs to be too complicated in terms of what we need to do to inflate growth, but it is building physician and provider champions at the account levels.

It’s making sure that we can systematize COSELA because extensive stage small cell is still a relatively rare tumor types. So, the more reminders we have in the system, and ideally leading to that EMR optimal placement, helps make sure COSELA was top of mind at the right time to be able to help patients. And then of course, these billing based contracts, it’s really a very similar thing, which is systemize the uptake of the product at an organizational level. If we got those things right, we will see more and more deeply of organizations, which ultimately allows us to generate that overall in the market, and will certainly give us the opportunity to have those targets.

Troy Langford: Okay. Great. And then just a clinical one for Raj. What – I guess in terms of the Phase 2 combination data with Trodelvy, 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?

Raj Malik: Yes. So, as I have mentioned, Troy, it’s really the overall survival data that we will be looking at, which will be the first quarter of next year. For the data, as well breast, what I will be looking at is, what is our patient population compared to San, for example, we have many more patients who have prior checkpoints compared to that study. So, evaluating the response rate and the early PFS data that context as well as the safety, but really, it’s the overall survival that we are most interested in looking at early next year in the first quarter.

Troy Langford: Great. Thanks guys.

Operator: Thank you. Please stand-by while we bring up our next question. Our next question will be from Anupam Rama with JPMorgan.

Unidentified Analyst: Hi, guys. This is Priyanka on for Anupam. Can you provide more granularity on the cash or cash flow in regards to the Simcere agreement?

John Umstead: 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 into the year.

Unidentified Analyst: Got it. Thanks.

Operator: Thank you. Please wait one moment while we bring up our next question. Our next question will be from David Nierengarten with Wedbush Securities. Go ahead, David.

David Nierengarten: Thanks for taking my question. I had a follow-up just thinking about the different toxins involved with ADC versus the chemo and triple negative breast cancer. I mean just going back to the read-through, and is that important to think about, if there is any read-through from the combo with Trodelvy versus the chemo backbone in next year in Q1, or is there any other data points we can extract from the upcoming data that would help to give people confidence in the backbone for Q1 next year?

Jack Bailey: So, David, just to understand, I knew and I asked him specifically for the ADC study or read through to the TNBC study just I am understanding your question.

David Nierengarten: Yes. 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 drugs partner, with a different mechanism of action to another study that has, two different chemo partners that have a different mechanism of actions. But are we – sorry to say it, but are we like wasting brain cells here trying to think about that until we just look at the trials in isolation from each other? Thanks.

Jack Bailey: Yes, That’s a good question. I think the strongest read-through to the TNBC Phase 3 is the Phase 2 data, right, which is the same doublet gem-carbo, and so where we saw the very strong effect. So, I think your point, the ADC trial will be an additional, important piece of information, obviously. But in terms of the Phase 3 TNBC trial, it’s really the Phase 2 TNBC trial with gem-carbo that provides the strongest evidence for what we may expect in that Phase 3.

David Nierengarten: Okay. Just wanted to triple check on that. Thank you, guys.

Operator: Thank you. Please stand-by for our next question. And our next question will come from Kaveri Pohlman with BTIG. Go ahead.

Unidentified Analyst: Hey. Good morning everyone. This is Christian here at BTIG. I will be asking the questions we are covering 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 predict this that might be useful in finding combinations for the future?

Raj Malik: So, this is Raj. So, are you referring specifically to the colorectal study here in terms of when you refer to a negative way, because we certainly have not seen that in small cell and TNBC, where we showed an improvement in survival, Just so I understand your question.

Unidentified Analyst: Yes. Colorectal cancer.

Raj Malik: Yes. So, there we are actually doing a number of investigations currently. And so when we have those data we will obviously release them. But yes, that’s certainly one of our hypotheses is, was there an unexpected interaction with 5-FU, that potentially resulted in T-cell.

Unidentified Analyst: 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 first CRC where 5-FU, how clear is the regimen that suggests that using trilaciclib before chemo is the best way to see the benefit versus with chemo or a little later after chemo?

Raj Malik: Yes. So, specifically for preclinical work, I mean we had done with 5-FU in combination, actually it was a checkpoint inhibitor was trila, which showed an improvement in efficacy. And we of course, had lots of data with a few showing that myeloprotection benefits. So, again, there was no – there was certainly no data pre-clinically to suggest that we would see what we saw in colorectal. And we also did that work with other chemo therapies as well. We are definitely expanding our work with looking at different chemotherapies now given this data to better understand it.

Unidentified Analyst: Okay. Thank you so much for providing that clarity.

Operator: Thank you everyone for your questions. I will now turn it back to Jack Bailey, CEO for closing remarks.

Jack Bailey: 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 will speak again soon.

Operator: Thank you everybody for your participation. This now concludes today’s conference call. You may disconnect.