G1 Therapeutics Inc (GTHX) 2022 Q3 法說會逐字稿

Hello, and thank you for standing by. Welcome to the G1 Therapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. (Operator Instructions) I would now like to hand the conference over to your opening speaker Vice President of Communications; Will Roberts. Will, please proceed. Hello, and thank you for standing by. Welcome to the G1 Therapeutics Third Quarter 2022 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. (Operator Instructions) I would now like to hand the conference over to your opening speaker Vice President of Communications; Will Roberts. Will, please proceed.

Thank you, Sheena. Good morning, everyone, and welcome to the G1 conference held to discuss our third quarter '22 financial results and business update. The press release on these financial results was issued this morning and can be found on the News section of our corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the third quarter of '22, 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 adult patients when administered prior to a platinum etoposide containing regimen or topotecan containing regimen for extensive stage small cell lung cancer or ES-SCLC.

A Q&A session, as Sheena said, 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 certain risks and uncertainties that could cause its actual results to differ materially from those expressed in or implied by these statements.

For more information on such risks 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, November 2, 22. Joining me on the call today are Jack Bailey, our Chief Executive Officer; Raj Malik, our Chief Medical Officer; Andrew Perry, our Chief Commercial Officer; and Jen Moses, our Chief Financial Officer. I'll now turn the call over to Jack. Jack.

Good morning, everyone. Thank you for joining us on the call today. During the third quarter, we demonstrated continued execution on our clinical program, but also experienced lower COSELA sales momentum versus what we achieved in the second quarter. I'll cover both in my opening comments, and then Raj and Andrew will each provide additional color to both topics. First, I'm proud of the progress the clinical team achieved. As Raj will discuss among the clinical milestones that we reached during the quarter and since our R&D Day in September, we announced this morning that we are seeing encouraging initial safety results from our Phase II ADC trial with sacituzumab govitecan that shows its potential to provide clinically meaningful reductions of over 50% in adverse events related to sacituzumab such as myelosuppression, diarrhoea and potentially even alopecia compared to previously published single-agent safety profile of this ADC.

We also completed enrollment in our Phase III metastatic triple-negative breast cancer trial and for our Phase II bladder cancer trial. And as we discussed on our last call, the trilaciclib mechanism of action trial. Next, our Phase II MOA trial results have been accepted for presentation at the San Antonio Breast Cancer Symposium meeting. Two abstracts providing additional nonclinical data on trilaciclib's potential antitumor effect have been accepted for presentation at the Society for Immunotherapy of Cancer meeting in November.

Finally, and perhaps, of most importance, our time lines for initial results remain intact for our pivotal Phase III trials in colorectal cancer and in triple-negative breast cancer. At the same time, we are cognizant of the fact that we did not deliver the level of sales results that we were expecting. As you'll hear from Andrew, we are working through some market variability due to new patient flow, pressure on organizational staffing and account additions at different times of the year, though this was balanced by a 12% increase in reorders from existing accounts.

We are putting in place a variety of actions that Andrew will describe that will drive growth over the coming months. We hear every day from health care professionals and patients who have experienced the unique benefit that only COSELA provides. It's a paradigm-changing drug that enables oncologists for the first time to proactively reduce or prevent the serious multi-lineage hematologic side effects of chemotherapy rather than treating them reactively. We remain as confident in the potential of COSELA today as ever. And as the initial results on our ADC trial underscore, extensive-stage small cell lung cancer is just the start. We are convinced of its potential value in much bigger markets like colorectal cancer.

Since this morning marks the first of many new clinical data disclosures over the coming months, I will first ask Raj to provide an overview of our clinical momentum during the quarter and since our R&D Day, starting with an overview of the initial ADC Safety results. Andrew will then cover our recent commercial actions and results, including an update on the efforts of our field sales team during the third quarter of 2022. Finally, Jen will provide the financial results for the quarter. And I'll be back for some concluding comments. With that, I'll turn the call over to Raj.

Thanks, Jack, and good morning, everyone. In September, we held our 2022 R&D Day and discussed a variety of topics, including the timing to the initial results and what to expect from those results and new preclinical data supporting the potential of trilaciclib to work synergistically with other anticancer therapies. We've made good progress on all fronts since then. I will start with the encouraging initial trilaciclib plus sacituzumab Govitecan Phase II safety results in patients with triple-negative breast cancer that we announced this morning. We are seeing consistent reductions by well over 50% in the rates of numerous adverse events associated with Sacituzumab when trilaciclib is administered prior to the ADC relative to the previously published single-agent safety profile of sacituzumab Govitecan.

We had hoped to present these data at a medical conference this fall, but small numbers at the time of abstract submission this summer precluded that. However, recent enrollment momentum provided the opportunity to evaluate key safety data in the first 18 of the 21 patients enrolled to date. Though early and unaudited, the trends in treatment-emergent adverse events have been consistent over the time, we have been monitoring the safety results of the study. Specifically, some examples of these reductions are in the rate of grade three and four neutropenia, which dropped from 52% in the sacituzumab data to 17% with trilaciclib and sacituzumab. The rate of any grade anaemia, which dropped from 40% to 6% and the rate of any grade diarrhoea, which dropped from 65% to 28%, with no occurrences of grade three diarrhoea with trilaciclib and sacituzumab and 11% in the sacituzumab data.

We view these as on target effects of trilaciclib, not only in the expected reduction in the rate of myelosuppression related to sacituzumab, but also in the rates of diarrhoea and potentially alopecia. This is likely due to the presence of CDK4/6 expressing cells in the intestinal crypt and in hair follicles. Though the data will continue to mature, we are very encouraged by these early on-target results as are the investigators who have reviewed the data because they begin to clarify the potential for trilaciclib in combination with ADCs such as sacituzumab govetican across other indications. In addition, these data could read through to the FOLFOX regimen in our colorectal study, which also includes arena (inaudible). We look forward to presenting a more comprehensive safety and efficacy data set at a medical meeting in the second quarter of 2023.

Next, I'll comment on our pivotal phase 3 trials. First, in PRESERVE 1, our 326 patient trial of trilaciclib in first-line metastatic colorectal cancer, the primary endpoints are assessments of the effect of trilaciclib on myelosuppression compared with placebo as measured by the occurrence of severe or grade four neutropenia during induction and duration of severe neutropenia in cycle one through four. We expect to release results in the first quarter of 2023 on myeloprotection and other on-target effects of trilaciclib, like diarrhea, which can be dose limiting in colorectal cancer patients receiving FOLFOX series.

This is a pivotal trial. If the myeloprotection data read out positive, we will meet with regulatory authorities to discuss filing for approval in this indication. Next, we recently completed enrollment in PRESERVE-2, our first-line triple-negative breast cancer pivotal trial in 187 patients with PD-L1 positive and negative tumors, receiving first-line trilaciclib or placebo prior to gemcitabine and carboplatin. We expect the interim overall survival analysis to be conducted by our data monitoring committee in the second half of next year. If the trial meets the interim analysis stopping rule, it will terminate, and we will report the top line results. If it does not, the trial will continue to the final analysis.

Next, let's shift to progress on other ongoing phase 2 trials. As we said during R&D Day, based on the mechanism of action of trilaciclib, we expect to see the greatest effects on longer-term efficacy endpoints like overall survival and progression-free survival and the least effect on response rate. We recently completed enrollment in PRESERVE 3, our phase 2 trial of trilaciclib in combination with chemotherapy and the immune checkpoint inhibitor, avelumab in 92 patients with bladder cancer. Initial safety and tumor response data are expected in the fourth quarter of this year, followed by data on the primary endpoint of progression-free survival in 2023.

As we have said, we do not expect to see myeloprotection in this trial likely as a result of the gemcitabine-containing backlog. Next, our abstract on the initial results of the phase 2 mechanism of action trial was accepted for poster presentation at the upcoming San Antonio Breast Cancer Symposium in December. The San Antonio poster will describe the initial immune endpoint results. Additional data, including pathological complete response and other immune and profiling data are expected in 2023. In September, we discussed new preclinical data describing the potential for trilaciclib to enhance the cancer immunity cycle by enhancing T cell activation, favorably altering the tumor microenvironment and improving long-term immune surveillance.

As Jack mentioned, two abstracts on this work have been accepted for presentation at the SITC 2022 Annual Meeting. In summary, we have made good recent progress, and we believe it positions us well for a data-rich period. Finally, I also will mention that we recently presented new data at the Precision Oncology Summit that continue to demonstrate the real-world impact that COSELA can have on severe hematologic adverse events and supportive care needs. In real-world practice, COSELA is used in a heterogeneous population of extensive stage small cell lung cancer patients. Despite this heterogeneity, COSELA consistently shows the potential to reduce the occurrence of myelosuppression, supportive care utilization and chemotherapy dose reductions and delay. With that, I'll turn the call over to Andrew for a commercial overview. Andrew.

Thank you, Raj. I'm glad to be with you today to provide an update on a number of commercial topics, including third quarter sales performance, factors affecting growth and the description of some of the actions we're putting in place that will drive growth going forward. The third quarter was our second complete period during which COSELA was promoted solely by our own team of GMO oncology sales account managers following the termination of our co-promotion agreement with (inaudible) in early March.

Our goal this quarter was to build on the platform of volume and growth, which we demonstrated in Q2. We delivered similar volumes in Q3 as generated in Q2. I'll discuss some of the factors affecting growth. Beginning with sales activity, we ended the quarter with $8.3 million in net sales of COSELA, representing approximately flat file volumes compared with Q2. Volume growth compared with the same quarter last year was 129%, demonstrating the overall progress we have made with sales execution. As you might recall, we sold quarterly growth of approximately 60% in Q2 of this year compared with Q1 but when we're reporting those results, we remarked that the small cell lung cancer market can be variable from month-to-month due to patient flow and pressure on staffing at health care organizations at different times of the year.

We've reviewed the most recent available patient level claims, and we estimate that the number of new extensive stay small cell lung cancer patients declined around 10% in the first two months of Q3 compared with Q2. As a reminder, in the expensive space 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. Similar to the same quarter last year, we added fewer new accounts in Q3 than in Q2. However, we did increase the volume of vials of reorders from existing accounts by around 12%.

We also added seven new top 100 organizations since the end of Q2, gaming as a total of 54 of the top 100 which have ordered COSELA launch today. As a result, our overall estimate of COSELA patient share in Q3 actually increased to nearly 8% in the first-line market, which represents the majority of our use. We saw 71% of volume in the quarter come through community clinics and hospitals and 29% of volume from academic centers, representing an uptick in demand in academic centers this quarter. 98% of our volume in the quarter was in commercial supply with 2% provided through our patient assistance program.

So our Q3 performance was driven by diminished numbers of new expenses face small cell patients in the market and fewer new accounts added, which together resulted in fewer new COSELA patients. However, this was balanced by more depth of reorders and existing accounts. Our payer mix remains stable with the majority covered by Medicare and third-party reimbursement has remained strong. COSELA brand awareness among oncologists remains high as does intention to prescribe. Face-to-face calls continue to compose the majority of sales engagements in Q3, and our measures of sales force effectiveness continue to exceed oncology industry norms.

Looking forward into Q4, with several new top 100 organizations having only recently come on board, we are moving quickly to ensure an initial trial becomes advocacy and then adoption. In reviewing opportunities for further improving execution in Q4, we introduced territory level sales incentive goals for the first time so that all of our sales account managers are highly incentivized to deliver growth in the quarter. We introduced new marketing claims, including patient-reported outcomes, which many oncologists believe are a pivotal reason for considering COSELA. We entered into negotiations for volume-based agreements with several large community oncology provider networks with one already finalized.

We anticipate beginning to see the impact of these in Q4. We also recently expanded our speaker bureau and completed our first live speaker training since launching COSELA. Finally, we made some operational changes including territory realignment, resulting in on fewer territory, making 33 in (inaudible). Overall, this was a quarter where we sustained the high levels of execution demonstrated in the prior quarter despite some challenges and flow of new patients. Going forward, although we anticipate some variability in month-to-month patient flow, we have 64 of the top 100 organizations and well over 500 accounts in total with COSELA experience.

Our customers strongly believe in the benefits of COSELA for their patients, and many are ready to share those experiences with their peers. This places us in a strong position to ensure that when new extensive stage patients are diagnosed, they have the opportunity to receive COSELA. Together with our new more patient-focused marketing resources, territory level sales incentives and select volume-based provider network contracts, we believe we're well positioned for stronger growth moving forward. With that, I'll turn the call over to Jen for a financial update. Jen.

Jen

Thanks, Andrew, and good morning, everyone. As Will mentioned, full financial results for the third quarter of 2022 are available in this morning's press release and will be in the 10-Q, which we intend to file after market close. Our total revenue for the third quarter of 2020 was $23.6 million, comprised of net COSELA revenue of $8.3 million and license revenue of $15.3 million. For the same period in 2021, total revenue was $4.9 million and included $3.4 million of net product revenue for COSELA and $1.3 million of license revenue. The license revenue from the current quarter is primarily related to revenue recognized from two development milestones related to the Simcere License Agreement, including a $13 million milestone payment related to the approval of COSELA in China.

Cost of goods sold for the three months ended September 30, 2022, was $1.1 million compared to $0.6 million for the same period in 2021. Our research and development expenses for the third quarter of 2022 were $19.6 million compared to $21.1 million for the third quarter of 2021. The decrease in R&D expenses was primarily due to a decrease in costs for manufacturing active pharmaceutical ingredients and drug product to support clinical trials. Our selling, general and administrative expenses for the third quarter of 2022 were $24.4 million compared to $24.3 million for the third quarter of 2021. Comparing the two periods, we saw increases in personnel costs due to increased headcount and administrative costs, offset by a decrease in medical fares costs, commercialization spend and professional and technology costs.

Regarding our cash position, as described in the press release this morning, we ended the third quarter with cash, cash equivalents and marketable securities of $123 million compared to $221.2 million as of December 31, 2021. We have amended our agreement with Hercules to provide additional flexibility with our covenants and have extended the time line we are able to draw the $25 million available to us into June of 2023. With that, I'll turn the call back over to Jack for some closing comments. Jack.

Thank you, Jen Andrew, Raj and Will. And as always, I want to thank people living with cancer for your inspiration. You drive the G1 team toward our goals every day. Before we move to Q&A, I just want to recap some of the points that you have heard today. We are very encouraged by the initial safety results from our phase 2 ADC trial of sacituzumab that show its potential to provide clinically meaningful reductions of well over 50% in numerous adverse events related to sacituzumab such as myelosuppression, diarrhea and even potentially alopecia. We expect to provide initial results from our two ongoing pivotal trials in CRC and TNBC next year, starting for CRC data in the first quarter of 2023 and from two additional phase 2 trials later this year.

The MOA data will be presented at San Antonio and the bladder cancer data will be issued via press release. We experienced lower close sales momentum versus what we achieved in the second quarter, largely due to variability in patient flow. And while we saw fewer new accounts coming on board during the quarter, this was offset by double-digit growth in existing accounts reordering. We've already initiated actions, including territory level of sales incentives, the addition of patient-reported outcomes in our marketing materials and volume-based agreements with several large provider networks.

We are confident that this will drive stronger COSELA growth over the coming months. Given the lower COSELA sales momentum, I do want to comment on our expectation for the remainder of 2022. As I said, we feel confident in the actions that we have put in place to drive COSELA growth rate, and we intend to provide formal guidance as soon as we have enough data on performance and impact. We anticipate that we will drive growth in the fourth quarter of 2023 over the third quarter as these initiatives roll out, and we expect that they will be effective as we head into and through 2023.

Thank you for your time this morning. We will speak again in this format on the fourth quarter and full year 2020 call. And as you've heard today, we'll have a variety of opportunities to communicate with you regarding initial data from our phase 2 and phase trial at medical meetings starting later this quarter and continuing throughout 2023. With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask the questions.

Thank you. At this time, we will conduct the question-and-answer session. (Operator Instructions) Please stand by while we compile the Q&A roster. Our first question comes from the line of Gil from Needham & Company. Gil, your line is open.

So maybe a first one for Andrew. I've never thought of small cell lung cancer is a seasonal disease. I mean, usually pretty aggressive patients go on therapy immediately. Can you explain kind of maybe the dynamics here?

No, I mean, I agree with you. I think once diagnosed, obviously, patients can progress very quickly. I think though there is a bit of a process in picking up those diagnoses. And we do hear from health care providers that the presentation of the symptoms that lead to a diagnosis are more likely at different times of the year. We've got signs, as I said, in the patient claims data that we looked at for Q3 that are available so far that, that is born true in those data that there was a decline of around 10% and new patients receiving any type of therapy for extensive stage in Q3. And then, of course, it's just harder to get hold of health care staff during that period to promote the products as well. So it's really a combination of those external factors that led to pure new patients going COSELA Q3.

And a couple of questions for Raj. First one, can you may be put in context the significance of reducing AEs with the specific ADC that was tested. Do you think the tax will lead to reduced the amount of treatment?

That's certainly what we are looking for in the study, right? So that myeloprotection and better tolerability will allow greater exposure, which should then allow greater efficacy of Trodelvy. That was actually a paper presented at ASCO, which showed a good relationship between exposure of Trodelvy to response. So that is exactly the rationale of behind conducting the study. So we're encouraged by what we're seeing from a safety perspective so far.

So the activity of COSELA which you've mentioned briefly, is there additional evidence? I mean, diarrhea got related to is a very common dose-limiting toxicity across chemo.

That's something that we've been following actually. We've done some work ourselves. There was a paper published, which showed that using a 4/6 inhibitor can actually reduce radiation-induced gut toxicity. And the hypothesis is that the serm-like cells in the intestinal crypt are dependent upon CDK4/6 for replication. So the similar protective mechanism that we see in the bone marrow could apply in the gut as well. I think SN-38, as you know is obviously causes a lot of diarrhea. And so we're encouraged by the early signs there. And as you also know, we pointed out in my remarks that irinotecan, which is, of course, the parent drug that gives rise to SN-38 and is part of the FOLFOX regimen also causes diarrhea in that regimen. So we'll be very interested to evaluate what happens to diarrhea in the colorectal trial also.

Our next question comes from Dan from RJS.

On the initial results that you're showing today for the combination of trilaciclib ahead of Trodelvy. Could you provide some more context for those 18 patients in terms of response rate in that cohort, how that compares to, I guess, the SN study and/or the number of cycles those patients had actually received of the ADC-based therapy and how that compares to maybe the median four cycles of therapy that were getting six to seven cycles that they were getting in the SN study. I think what we're looking for is a subway compare in understanding whether the table that you have presented today is within the context of drug exposure that those patients would have gotten in the comparable study.

In terms of responses, we have seen responses in the study, first of all. As I mentioned, the enrollment in the early part of the study was actually pretty slow. The first patient was enrolled in January. So we do have some long-term data to evaluate safety. However, the bulk of the patients actually have come on in the last, say, three-plus months. So it's really still early to make a true assessment of what the response rate could be. But clearly, as you know, toxicities like neutropenia and diarrhea do happen early on. And if enough patients have received enough cycles for us to make that assessment. And that was the reason why we thought it was important to put out these data.

But ultimately, the goal, as you know and as Gil also asked, is to extend the duration of therapy on Trodelvy to allow us to not only potentially improve responses, although as we've mentioned before, we don't really anticipate seeing an improvement in responses based on the mechanism of action. It's really more on extending those longer-term events such as PFS.

Just follow up on that. What was the -- for the 18 patients that you included in the preliminary safety data set, what were the criteria you used for including them in that valuable cohort in terms of exposure to sacituzumab again (inaudible).

Patients have to have completed at least 1 cycle on therapy and received certainly the combination of trials plus sacituzumab.

Do you have a breakdown of how many patients are included in the AE table that had more than one cycle of sacituzumab?

Yes. Actually, the vast majority have had more than one.

And you can't disclose what the ORR is for that cohort. I don't think people are really looking for you to be better. They just want to make sure that for this table, it's comparable, which then validates the 80 cross comparison that you're trying to make.

As I said, I think there is a difference between exposure from a safety assessment and exposure from an efficacy assessment. Even though with Trodelvy, some of the responses happened early, like in the first cycle, there are a significant number that happened with additional cycles. So I think it's really hard to make a call right now from an efficacy standpoint, a response rate standpoint, I think the data would really not be mature. So all I can comment is we have seen responses. So we're encouraged from that perspective. And of course, we are interested in seeing that as well before we put out this data. I can't directly answer that question.

So let me ask you this way, which might be helpful to people on the line. It sounds like to be comparable in terms of drug exposure of the ADC to Ascend, these patients, the 18 patients that you have here still need more cycles of sacituzumab govitecan. So possibly, the AE table you're showing could go up in some of these rates. Do you have an idea of -- for the comparison ultimately of the cohort, what you think is clinically meaningfully different for some of the key event rates, (inaudible) neutropenia, thrombocytopenia, whatever you want to pick, that would be the target product profile that you're hoping for with the study.

As I mentioned, we've been following the safety data really right from the beginning, right? That's what you do in any trial. And so, the rates for both the neutropenia and the diarrhea, have remained relatively actually consistent with what we've put out there with additional patients that have been enrolled. You're absolutely right. The numbers will definitely change with increased just with more patients in general and definitely with exposure potentially as well. But it has been consistent from -- kind of from the beginning. In terms of what are the most meaningful AEs where we would hope to show an improvement, it's really neutropenia and its consequences, including febrile neutropenia.

Of course, I think diarrhea is a really intriguing early finding, I would say. And if you look at the sacituzumab label, those are the two warnings on the label. So that's something else that we're following closely. Of course, we're encouraged with the effect on anaemia as well, which speaks to sort of the multi-lineage early indicators of effect here.

Just when do you expect to complete enrolment page. Did I understand that correctly that you have 21 enrolled now, so you'd still need 24 to hit the enrollment target in the study?

Yes, we're talking approximately 40%, but potentially even -- and we're hoping by the end of the year that we'll have the required number of patients, and we'll present, as I said, the safety and the efficacy data set in the second quarter of next year. That's our target.

Thank you, Dan. Please stand by while we bring the next question. Our next question comes from Ed from H.C. Wainwright. Ed, your line is now open.

So you had mentioned in the third quarter, the diagnoses were down and it could be due to some seasonality. What is the historical trend for the fourth quarter as far as diagnosis goes? Do you have any of that information for small cell lung cancer?

I would say that the way we track it is through patient claims. So it's really patients going on to therapy for the first time rather than tactically diagnoses. So it's patients going on to the top side platinum with or without (inaudible). Yes, looking at seasonality, and it can be very most to month. For example, in August was our best month launch today within the quarter within a relatively flat quarter. So it can certainly be very month-to-month. Looking back at Q4 of last year, initial growth and quarterly growth in Q4 last year, I think of around 20%. But clearly, there are periods perpetually towards the end of Q4, where there might be some seasonality. But overall, Q4 last year contained also some of our highest months at that point. So we believe with our improved capability in the marketplace that we have this year and with some of the new tactics to discuss, we're looking forward to a good Q4.

And a couple of questions for Jen. R&D expenses were down the last two quarters sequentially. SG&A expenses were also down sequentially each of the last two quarters. I just wanted to know if we can get any of your thoughts on the fourth quarter.

I would say I think we're going to be in line. I would expect R&D actually to be a little bit higher next quarter just because we're coming up on data readouts, and there are some -- as we do the stats and everything is at that tends to add cost. But as these studies going down but complete or just having sites and patients that we're not having to pay for any more. So those costs will continue to come down. For SG&A, I would expect it to stay pretty in line with what we have, not anticipating any major changes there.

And can you give us any guidance on cash runway?

So I think before we have given guidance into '24, I think in light of that, guidance was based on a couple of things. The utilization of the $25 million from Hercules, which we haven't pulled down yet and also a continued sales ramp up quarter-over-quarter. As Andrew just alluded to, we are seeing more variability in the sales line. So not giving guidance to 24 at this time, although we do have scenarios that get us there.

Thank you, Ed. Please stand by for the next question. Our next question comes from Anupam from JPM.

What are some of the key marketing hurdles or pushback that you're hearing in terms of getting new prescribers onboard with COSELA?

The barriers remain the same that we've been dealing with over the last year or so, which is, first of all, understanding the extent of the problem of myelosuppression because those reduction has become a way of life. And of course, that can diminish the effectiveness of the chemotherapy treatment. We actually know hard-red evidence that's been presented at conferences and which is in our promotion which shows with thousands of patients in the real world, the true extent of myelosuppression and it really is an incredible burden on patients with real consequences in terms of hospitalizations, et cetera. So we feel we're in a good position from a marketing perspective to tell that story.

The next part is, with many of these organizations, they do have complex processes to get the new products into consistent use. And so, moving from trial to adoption usually involves going through a high-risk patient that may be the first patient that they trial with seeing that benefit in that patient and then wanting to use it with all the eligible patients. To do that, you have to go through a formulary process, an EMR addition or present addition. And it can take some time to work through that. And certainly, in Q3, it was tougher to move from trial to adoption just because getting all of those staff members together, having all of those conversations means appointments, means taking time and start aren't available to do that because of seasonal vacations or whatever, it could just slow the process down.

And then finally, we have to make sure that we are persistent in our efforts because not many providers see a lot of expenses by small cell patients. So we have to get out there. We have to expand our peer-to-peer efforts. We have to expand our digital efforts, and we've actually made incredible strides forward over the last few months with that, not only our digital efforts.

But as I mentioned before, expanding our speaker view role, having us first life to live speaker training. It was fantastic to see the energy in the room from our speakers who have experience with COSELA as they really advocated with their peers for it, and we're looking forward to sharing their real-world stories.

Thank you. Please standby for our next question. And the next question comes from David from Wedbush Capital.

Two quick ones. First, could you remind us what was other -- any other support agents, the Neulasta or whatever allowed for patients in the triple-negative study. And then as a quick follow-up, in the SN study, Neulasta, I think, was allowed after the first cycle of Trodelvy. Do you know if there are continued problems with neutropenia if you were to prophylax with CFS or what the rates might be of severe neutropenia in patients who might have a pre-treatment with it?

Yes, so we allowed supportive care, including growth factors and transfusions and so on. And you're right that it was also allowed in the SN trial. I'm trying to recall what proportion received GCSF, I seem to have all around -- I think in that kind of range. So yes, so that's something clearly we are following as well in our study. But given the lower rate of neutropenia, we would expect that to be a lower proportion in the combination with China.

And did any patients receive it so far in your study? CSF?

I'm not aware of that.

Thank you. Please stand by for our next question. And our next question comes from (technical difficulty) of Cowen & Company.

I just have two questions on CRC. Maybe one for Raj and then one for Andrew. So first, on the CRC data next quarter, can you just remind us of your expectations for the data? And maybe like what level of neutropenia reduction will make you all feel excited? And then for Andrew, on opportunity in CRC, do you all have any idea how the top goal accounts compared to those in CLC? Do you all see a lot of overlap there and if so, do you think you could possibly penetrate the market much faster given the established relationships that you already have at some of these centers?

So this is a phase 3 trial, and we have obviously defined the staffs in a way to see the reduction, right? So just to give you a context for colorectal with FOLFOX series based on the (inaudible) data, we expect a grade four neutropenia rate in about the 20-odd percent rate and the trial is designed to show a statistically significant reduction over that. And if we meet that, I think that's going to be clinically meaningful. So I hope that helps answer your question. I think that would be exciting because, as you know, the major hurdle for continuing FOLFOX series is really myelotoxicity. So if we're able to improve upon that, we believe that's going to be a benefit for patients.

I'll tip in on the second one. Yes, so I do think there will be significant overlap, and that will be particularly in the community staffing, where community oncologists really see all-comers. They’ll have a specialist within the network or within the office, but they often they'll see multiple tumor types. I think in the academic center, that center at will be a little different, and we will have to engage with them both through our medical Advairs organization as well as commercially to be able to get to those folks. But I do think a lot of CRC is treated in the community. So I do think there will be overlap there. Also in terms of the speed of uptake, probably the single biggest thing on the west list of our COSELA campaigns out there today is, when are you going to get more tumor types. I want to be able to use this with more of my patients. And so I do think that we will see some early adoption and people who just become more familiar with Colella by having multiple tumor types and the indications. So our customers are telling us they are incredibly excited about our future potential and we can to deliver that volume to.

Our last question comes from Tony from Roth Capital.

If we go back to the triple negative breast cancer data with Trodelvy, treatment interruptions, if you just do the straight math from the label of SN are in 63% of patients and which lead to treatment interruptions in roughly half or 47%. If you actually run the numbers on the 18 patients, five patients would've request -- at least would have that dose interruption. Is there that why you're making the statements about a reduction in 50%? I'm trying to frame this correctly.

That’s question one if I may. Question two is, Andrew, I believe in Q2 you made reference to sales reps having some level of increase in face-to-face contact. If I've characterized it correctly, is that the same in Q3? Has it increased? Are we in the fifth inning that you would have expected to occur? Or is it too early to say? And then, finally, do you get data? Is it only after the fact on surgeries per center or do you get it as granular as the type of surgery per center when you look at your data on a quarter-to-quarter basis? Thanks very much.

So yes, I mean, I think that certainly dose delays, dose reductions is something we're following very closely. Obviously ongoing study, but we're encouraged by what we've seen to-date, I think is all the color I can provide at the moment.

And I'll chip in Tony. Yes, so face-to-face is over 70% of our engagements are face-to-face. It has gone off markedly since we introduced our new sales team, which is fantastic. Really interesting, as I mentioned it before, but although we saw access to customers a little bit limited in Q3 because of those seasonal variations, our share voice actually remains stable during Q3. So that basically means that all companies have limited access to customers during that period, which again lends itself to the fact that there's some seasonality there. But overall, we've been very, very pleased with the ability of our folks to get customers and have substantive face-to-face discussions. In terms of the last question, I'm not sure if I was quite tracking with you, and maybe Raj can answer, but we don't track any kind of surgical procedure data in our commercial setting, anything.

But you alluded to the fact that small cell lung cancers were down 10% in Q3. Is that the way? Did I correctly hear that? So you had to actually track something that had information about surgery whether or not it's diagnoses or otherwise I assume all these patients would have surgery.

No. Great, great point. Thanks for the clarification. Actually, so it's based on claims data for etoposide platinum with or without atezolizumab. And with or without the presence of a diagnosis of extensive stage in the vast majority of use for that regimen is obviously extensive stage. So that's how we judge that. So, it's basically a paid claim for that regimen. We'll tell us how many new to line patients are existing in the marketplace, but it's not related to the surgical procedures that would accompany that.

Thank you, Tony. I would now like to turn it back over to the CEO, Jack Bailey for closing remarks.

Thank you, Operator. As always, we look forward to keeping you all updated as we progress. Certainly, thank you for joining us today. Please stay well and we'll be in touch.

Thank you so much. This now concludes the call. We will now disconnect the line.