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G1 Therapeutics, Inc. (GTHX -1.88%)
Q2 2022 Earnings Call
Aug 03, 2022, 8:30 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good day, and thank you for standing by. Welcome to the G1 Therapeutics second quarter 2020 financial results call. [Operator instructions] Please be advised that today's conference is being recorded. I would now like to hand the conference over to your first speaker for today, Mr.

William Roberts. Please go ahead.

Will Roberts -- Vice President, Corporate Communications and Investor Relations

Thank you, Mike. Good morning, everyone, and welcome to the G1 conference call to discuss our second quarter '22 financial results and business update. The press release on these financial results was issued this morning and can be found in the news section of our corporate website, g1therapeutics.com. On this morning's call, the team will provide a business overview of the second 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 question-and-answer 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 risks and uncertainties that could cause 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.

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Any forward-looking statements represent our views as of today, August 3, 2022. Joining me on the call today are Jack Bailey, our chief executive officer; Andrew Perry, our chief commercial officer; Raj Malik, our chief medical officer; and Jen Moses, our chief Financial Officer. And with that, I'll turn the call over to Jack.

Jack Bailey -- Chief Executive Officer

Thanks, Will, and good morning, everyone. Thanks for joining us on the call. Today's headline is that we have achieved a variety of important foundational milestones that we set for ourselves for the first half of 2022. I'll briefly touch on three of them.

First, I'm proud of the decisiveness and strategic execution shown by the G1 team over the past few quarters regarding the commercialization of Cosela. We identified the issue of needing to better access top target prescribers and accounts. We made the right decisions quickly and executed decisively to correct course, including building our own Cosela focused sales team. And as a result, during the quarter, we saw an inflection in sales.

The momentum we experienced in the quarter is evident as our team worked to bring this innovative drug to more patients with small cell lung cancer than ever before. Cosela is an important and unique drug. It is proactively administered and covers multiple lineages, enabling oncologists for the first time to reduce or prevent the serious hematologic side effects of chemotherapy pre-emptively rather than waiting for treating them reactively with a variety of single lineage interventions, which, of course, carry their own unintended and potentially pageous consequences. As you'll hear from Andrew, we experienced good growth during the quarter, including growing vial volume by almost 60% period over period.

Second, the team has executed the majority of our clinical programs extremely well during a period of significant headwinds, including COVID-19 and the ongoing crisis in Ukraine, which impacted many clinical trials of different products. Most importantly, we achieved the important milestone in the second quarter of completing enrollment in our Phase 3 line extension trial of trilaciclib in 326 participants with metastatic colorectal cancer. We expect the initial results, including those from the primary endpoint in the first quarter of 2023. And as you read in this morning's press release, we recently also had key enrollment milestones in both our Phase 2 bladder and our Phase 2 trial assessing the mechanism of action for trilaciclib.

Further, as you will hear from Raj, we expect to provide the initial results from each of our five ongoing Phase 2 and Phase 3 clinical trials over the coming 18 months starting in the fourth quarter of this year. Third, from a corporate perspective, we were recently very pleased to share that the China National Medical Products Administration had conditionally approved the marketing authorization for Cosela which was jointly developed for use in Greater China in partnership with Simcere. As a result, G1 will receive a $13 million milestone payment from Simcere, part of a total milestone consideration of up to $156 million. We also expect to receive double-digit royalties on future annual net sales of Cosela in China, which Jen will describe later in the call.

This morning, I will first ask Andrew to cover our recent commercial progress, including an update on our efforts of our new field sales team during the second quarter of 2022. Raj will then provide a snapshot of our clinical momentum, including time lines and data expectations. Finally, Jen will provide the financial results for the quarter, including an update on financial ramifications of the sincere approval and a reminder that our cash runway takes us into 2024. Then I'll be back for some concluding comments.

With that, I'll turn the call over to Andrew.

Andrew Perry -- Chief Commercial Officer

Thank you, Jack. I'm glad to be with you today to provide an update on a number of commercial topics, including second quarter sales performance and leading indicators of growth. The second quarter was our first complete period during which Cosela was promoted solely by our own team of G1 Oncology sales account managers or OSAM following their full deployment in mid-February and the termination of our co-promotion agreement with Boehringer Ingelheim in early March. Our goal in the second quarter was to demonstrate significant volume growth with a focus on the top 100 organizations who see around 50% of patients with extensive-stage small cell lung cancer.

We also wanted to build a patform for future growth by demonstrating both breads and depth of utilization across the U.S. Beginning with sales activity. We ended the quarter with $8.7 million in net sales of Cosela, representing nearly 60% vial volume growth quarter over quarter. This was our highest quarterly growth rate since the initial launch period and has almost tripled the growth rates we saw in Q4 of last year and in Q1 of this year compared to the same quarter in 2021, which was our first full quarter after launch, the growth in vial volume was 268%.

Each month in the second quarter showed positive month-over-month growth in volumes. However, the small cell lung cancer market can show variability from month-to-month due to patient flow and pressure on staffing and healthcare organizations at different times of the year. And similar to last year, our rate of growth in July did not reflect the pattern we saw in prior months. However, we do anticipate continued quarter-over-quarter growth, and we've taken the opportunity to initiate a number of sales and marketing initiatives designed to further improve our execution and restore stronger growth.

We saw 77% of volume in the quarter come through community clinics and hospitals and 23% of volume come from academic centers. 98% of our volume in the quarter was in commercial supply with 2% coming through our patient assistance program. And our pair mix remained broadly unchanged with 65% covered by Medicare, 27% covered by commercial and the remainder in Medicaid or government programs. As I mentioned earlier, our goal was to not only deliver higher growth, but also to deliver a platform for future growth by broadening our base of utilization and driving depth in key accounts.

I'm pleased to report that all four of our sales regions in the U.S. contributed to our national quarterly growth with regional growth rates during the quarter, ranging from 22% to 85%. In fact, 13 of our 34 territories demonstrated growth of over 100% in the quarter. We also wanted to expand our reach and uptick in the important top 100 organizations, which treat around 50% of patients with extensive-stage small cell lung cancer, and we have added seven top 100 organizations since the end of Q1, giving us a total of 60 of the top 100 which have trialed Cosela.

Approximately 80% of those organizations had repeat orders during the second quarter. The proportion of our Q2 business in top 100 organizations was 53%, and our portfolio growth in those top 100 was 52%. Moving to some matters of overall commercial execution, Cosela brand awareness remains high at around 80%, with over 90% of physicians who are aware of Cosela intending to prescribe within 12 months and over 50% intending to prescribe within three months. Message effectiveness for the majority of Cosela messages is at or above oncology brand industry averages.

Third-party payer reimbursement has remained strong, and we have had very few payer rejections to date. We've also seen an increase in opportunities for face-to-face engagement with customers, with the majority of our calls now in person, and we were excited to have our commercial and medical teams representing G1 Therapeutics and Cosela at major conferences such as ONS and AFFO this quarter. Overall, we're pleased with our progress in Q2. We delivered significantly stronger growth and built a broader base of business across the key customer organizations, which can continue to support growth going forward.

Our key lead measures of success all show even more potential for Cosela In the future. As a result, we remain ambitious for the potential of Cosela to benefit many more patients with extensive-stage small cell lung cancer, and we're committed to ensuring their healthcare providers have the necessary information and resources to include Cosela in their regimens. With that, I'll turn the call over to Raj for a medical and clinical update first.

Raj Malik -- Chief Medical Officer

Thanks, Andrew, and good morning, everyone. As Jack mentioned, I can report that as of today, we expect to provide the initial results from our five ongoing clinical trials in the time lines we have previously disclosed. As context for the studies, where assessment of antitumor efficacy is the primary objective, it is important to understand the Phase 2 triple-negative breast cancer data that were published in 2019 in Onset Oncology as we think about the initial and final data that will be reported in the fourth quarter of this year and through 2023. As you may recall from the TNBC Phase 2 data, we observed robust statistically significant improvements in the most clinically meaningful endpoint of overall survival in patients receiving trilaciclib compared to patients in the control group with hazard ratios of 0.31 and 0.4 in the two trilaciclib groups.

The effect on progression-free survival was strong, but not as robust as overall survival. And the least difference between the trilaciclib arms and control was in response rate. Our hypothesis are expecting to see a greater effect on EFS and OAS compared to response rate is that the immuno-modulating mechanism of action of trilaciclib could improve survival more so than response rate. This is consistent with data from therapies that modulate the immune system such as immune checkpoint inhibitors.

Specifically, we believe that the durability of effect may occur through increased formation of memory CD8-positive T cells, which could improve long-term immune surveillance. Therefore, for our Phase 2 studies focused on assessing antitumor efficacy, we expect to see a greater effect of trilaciclib on progression-free or overall survival and the least on response rate. I remind you of our expected time line for data over the coming 18 months, starting with our Phase 3 Pivotal trials and then moving on to our Phase 2 program. First and foremost, we recently achieved an important milestone as we completed enrollment in our 326 patient trial of trilaciclib in first-line metastatic colorectal cancer called Preserve 1.

[Inaudible] is the most effective and also the most myelotoxic regimen for metastatic colorectal cancer. Improving myelotoxicity could result in a greater exposure to chemotherapy and potentially also improve antitumor efficacy. We expect to release initial results from this trial, including those from the primary endpoint of myeloprotection and from the secondary endpoint of overall response rate in the first quarter of 2023. The secondary survival endpoints of PFS and OS will come later.

If the myeloprotection data are positive, we will meet with regulatory authorities to discuss filing for approval in this indication. Second, regarding Preserve 2, our first-line TNBC pivotal trial in approximately 170 patients with PD-L1 positive and negative tumors, 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, regarding our Phase 2 trials. We currently expect initial data from the following three in the fourth quarter of this year. Starting with Preserve 3, our study of trilaciclib with chemotherapy and the immune checkpoint inhibitor of avelumab in patients with bladder cancer receiving first-line treatment. As Jack mentioned, we announced this morning that we have achieved our target enrollment in this approximately 90 patient trial.

The last two patients who have consented to enroll should do so shortly, so we should achieve last patient in, In the upcoming days. As such, we can confirm that we expect to provide initial top line response rate and mono protection data in the fourth quarter of this year, followed by data on the primary endpoint of PFS in 2023. Second, we've also completed enrollment in our 24-patient trial to clarify the mechanism of action of trilaciclib in participants with neoadjuvant triple-negative breast cancer. We expect to provide initial immune endpoint results from this trial, including trilaciclib's impact on CD8-positive T cells and regulatory T cells or T regs in the tumor microenvironment in the fourth quarter of this year with pathological complete response and other immune profiling data in 2023.

Third, we expect to present preliminary safety data from our Phase 2 trial in triple-negative breast cancer designed to evaluate the additive combination potential of trilaciclib with the antibody drug conjugate, sacituzumab govitecan. The treatment landscape has continued to change in the U.S. with greater usage of pembrolizumab in the neoadjuvant and adjuvant setting, resulting in slower progression of disease, which is great news for patients. As a result, the time until a patient could become eligible for our trial has pushed out, which appears to be one of the factors that has contributed to slower enrollment.

We are in the process of mitigating this in a variety of ways, including adding additional sites. As a result, we'll have preliminary safety data late this year from as many patients as possible and the bulk of the data, including efficacy next year. It's worth noting that this landscape evolution is a U.S. effect only.

We are not seeing these enrollment hurdles in the global Pivotal TNBC trial. Finally, there are significant strategic importance to expediting the evaluation of the combination of trilaciclib with a checkpoint inhibitor and chemotherapy in first-line non-small cell lung cancer. As such, rather than supporting an investigator-initiated study, we're exploring other means of evaluation such as sponsoring it ourselves or with a partner. We will provide an update on this as soon as possible and also keep you abreast of our ongoing ISS program as those trials initiate.

With that, I'll turn the call over to Jen for a review of the financial results for the second quarter of 2022.

Jen Moses -- Chief Financial Officer

Thanks, Raj, and good morning, everyone. As Will mentioned, all financial results for the second quarter of 2022 are available in this morning's press release and will be in the 10-Q, which we intend to file today after market close. Our total revenue for the second quarter of 2022 was $10.6 million, comprised of net Cosela revenue of $8.7 million and license revenue of $1.9 million compared to $6.6 million of total revenue for the same period in 2021. Cost of goods sold for the three months ended June 30, 2022, was $1 million compared to $0.8 million for the same period in 2021.

As a reminder, a portion of the manufacturing costs related to Cosela sales were incurred prior to FDA approval and therefore, were recorded as R&D expense in prior periods. The majority of prelaunch inventory has been depleted, and the treatment of these costs will now have a nominal impact on cost of goods sold going forward. Our research and development expenses for the second quarter of 2022 were $20.8 million compared to $18.8 million for the second quarter of 2021. The increase in R&D expense was primarily due to an increase in clinical trial spend, offset by a decrease in cost for manufacturing of active pharmaceutical ingredients and drug product for clinical trials.

As we mentioned on the last call, we expect annual 2022 R&D spend to come in above 2021 level with the first quarter of 2022 as the outlier, and the third and fourth quarter more in line with what we saw in the second quarter of this year. Our selling, general and administrative expenses for the second quarter of 2022 were $25.7 million compared to $25.2 million for the second quarter of 2021. The increase in SG&A expenses quarter over quarter was largely due to an increase in personnel costs related to headcount, offset by a decrease in medical affairs cost, commercialization activities, professional and legal fees and IT-related costs. We continue to monitor our expenses in a disciplined manner.

While we are investing in customer-facing commercial activity and prioritizing spend that allows us to meet enrollment and data readout time lines for our trials, we are continuing to monitor other ancillary expenses. We have reduced or delayed spend in many areas while we allow time to grow our product revenue line. Regarding our cash position, as described in the press release this morning, we ended the second quarter with cash and cash equivalents of $144 million compared to $221.2 million as of December 31, 2021. We expect this to be sufficient to fund our operations and capital expenditures into 2024.

This projection of cash runway includes a future draw of an additional $25 million on our debt facility with Hercules, which is currently available to us at our discretion. As Jack mentioned, we will receive a $13 million milestone payment in the third quarter from Simcere as a result of their recent approval of Cosela in China. We also expect to receive double-digit royalties on annual net sales of Cosela in China. Although we may earn some royalties this year for our internal modeling purposes, our assumptions are that these royalties will begin in 2023.

With that, I'll turn the call back over to Jack for some closing comments. Jack?

Jack Bailey -- Chief Executive Officer

Thank you, Jen, Raj, Andrew, and Will. And as always, I want to thank people living with cancer for your inspiration. You drive us toward our goals each and every day. Now before we move to Q&A, let me just recap some of the points that you've heard today.

The second quarter was our first full period during which Cosela was promoted solely by our own team of G1 OSAMs following their deployment in mid-February. We ended the quarter with nearly 60% bile volume growth quarter over quarter. This was our highest quarterly growth rate since the initial launch period. Third-party payer reimbursement has remained strong, and we have had very few payer rejections to date.

During the quarter, we completed enrollment in our Phase 3 registrational trial in colorectal cancer and more recently completed enrollment in our Phase 2 mechanism of action trial and hit our enrollment target in our Phase 2 bladder cancer study. And finally, as Raj described, we expect to provide initial results from our two ongoing Pivotal trials in CRC and triple-negative breast cancer next year, starting with the CRC data in the first quarter of 2023 and data from our three Phase 2 trials later this year, the bladder study, the MOA study and the ADC combination studies. Now regarding Cosela guidance, as we have previously communicated, we intend to provide formal guidance as soon as we have enough data on performance and impact of our G1 sales team to do so. However, given the month-over-month tempering of sales in July, we need a better understanding of these market dynamics before we can do so.

As such, as of today, we remain comfortable with analyst consensus for Cosela net sales in 2022, currently sitting just under $40 million. With a strong quarter of sales under our belts and a data-rich period through the end of 2023 ahead of us, I could not be more excited about where we are heading and the potential for trilaciclib to impact the lives of many patients living with various cancers. Thank you for your time this morning. We will speak again in this format in November on the third quarter 2022 call.

However, you will hear from us next at our upcoming virtual R&D Day on September 15. We expect to discuss a variety of topics, including a more robust discussion on the trilaciclib mechanism of action, readouts from our preclinical work assessing the potential synergies with other anticancer drugs, updates on our clinical program and data expectations and the future potential of trilaciclib, all ahead of the key readouts from our clinical trials. So please keep an eye out for invitations and dial-in instructions over the coming weeks. With that, I will close the call and turn it over to Q&A.

Questions & Answers:


Operator

Your first question comes from the line of Gil Blum of Needham & Company.

Gil Blum -- Needham and Company -- Analyst

Congrats on the progress. So we kind of discussed a few potential items on the commercial side that show signs of improvement. I'm just curious as to what is the company's view on the most important factor in driving future growth. Is it adding more top 100 facilities? Is it improving penetration in those facilities.

Whichever you think is the most important.

Andrew Perry -- Chief Commercial Officer

Yes. Gil, happy to take that. Yes. I think you nailed it, but we've obviously got to a significant portion of those top 100 right now.

Those 60 organizations that we have now seen in order from. And of course, we've seen an 18% reorder rate from those organizations, which we're really happy about. But the overall depth of penetration has just a ton of potential there. Clearly, there is a lot of runway even within the 60 organizations that have already ordered the product to actually see increased uptake.

Very often with these types of organizations, there's a period where they initially use the product, they take a look at the results, but it might not be on all of their pathways or in all of their systems. And there's a period of us optimizing the placement of the product and then communicating how to use the product across all of the satellite locations. And that's the process that we're in the middle of right now. We've actually seen in Q2 some amazing success in some organizations through doing that process.

And so that's where our team is really focused on in Q3 and Q4.

Gil Blum -- Needham and Company -- Analyst

And considering that several of your clinical studies have completed their enrollment, should we expect a slowing in R&D operation expenses moving forward? Or just kind of remaining flat?

Jen Moses -- Chief Financial Officer

I would expect it to remain flat. The studies are enrolled, but we will have data processing. We'll have just a number of things to close out studies, so I would estimate them to be around where they were for the second quarter and continue that going forward.

Operator

Your next question comes from the line of Kaveri Pohlman of BTIG.

Kaveri Pohlman -- BTIG -- Analyst

So for TNBC, has the change in treatment landscape impacted enrollment in the first-line TNBC Phase 3 trial?

Jack Bailey -- Chief Executive Officer

Yes. Thanks for the question, Kaveri. This is Jack. It has not changed the enrollment time line on the Phase 3 first-line TNBC.

That's a global study so we've got an enormous number of sites outside of the U.S. The ADC combination study is solely a U.S.-based study and since Keytruda's approval at the end of 2020 -- or 2021, I guess it was, it's only impacting the U.S. sites in terms of a bit more watch and wait in these patients taking longer to get to a time where they would be eligible for our study. So no on the first-line Phase 3.

Kaveri Pohlman -- BTIG -- Analyst

For TNBC, do you expect in the use of Keytruda in the neoadjuvant adjuvant setting to impact trilaciclib efficacy in the first-line setting? In patients who previously received and progress on this immunotherapy.

Raj Malik -- Chief Medical Officer

I can take that one. We do not. Based on the mechanism of action of trilaciclib and its impact on various aspects of that cancer immunity cycle, we think that there is a potential that we could work even in patients who have previously received an immune checkpoint inhibitor.

Kaveri Pohlman -- BTIG -- Analyst

Thanks and congrats on the progress.

Operator

Next question is from Tony Butler of ROTH Capital.

Tony Butler -- ROTH Capital Partners -- Analyst

Andrew, you made a comment about July and then you made a statement about some sales initiatives, and I didn't quite get what those sales initiatives might be. I wondered if you could make a statement about if you could, about what those new sales initiatives would be. And then two additional questions. Raj, on the Preserve 2, while you're enrolling PD-L1 positive and negative patients, is there a net number of PD-L1 positive versus negative patients that are most desired from the 170 because even though you have seen some positive data in both cohorts, it's not exactly equivalent that could play into this futility next year? And then finally, when you mentioned you'll make comments about myelopreservation, for example, in CRC in Q1, exactly what can you say about myelopreservation given the trials continuing.

Andrew Perry -- Chief Commercial Officer

Yes. Obviously, in oncology, patient flow in the summer months can come a little bit, and it does appear to have been affected by some trends in patient flow and perhaps healthcare staff availability as well for various reasons. I did mention a couple of the initiatives that are underway. And so the first is just that, focusing on those high-growth opportunity accounts at the national, regional and territory level and creating some accountability around progress there.

We're also developing an early warning system, which will highlight accounts to us when they drop in utilization because quite often, that's not because of a lack of confidence or excitement of the product. It's often just due to a process issue which we can actually intercept much earlier if we flag it earlier. We're also following through more effectively where we see a patient come on board to make sure the providers of all the information they need about how to use the product appropriately. We shifted some digital advertising to focus on our key accounts, and we have some new marketing materials and resources coming out in Q3 as well to keep our messages front of mind.

So we've taken the opportunity to sharpen execution across a number of elements of our commercial model.

Raj Malik -- Chief Medical Officer

So initially, for the first Preserve 2, you're right, we're enrolling all comers of PD-L1 positive and negative. If you look at the data, approximately 40% of patients have PD-L1 positive tumors. We are stratifying by PD-L1 status. So we anticipate that the approximate distribution of PD-L1 in this tumor population is what will be represented in the trial.

So in that 40% to 50%. And because we're stratifying, we think iit's the appropriate way to evaluate the effect in both. And even in the PD-L1 negative, if you recall, the hazard ratio was still less than 0.5%. So there was definitely a meaningful effect there.

And then to Preserve 1, the data that we'll be analyzing and reporting will be the primary and key second data, so duration of severe neutropenia, severe neutropenia and patient-reported outcomes. We will be blinded to any event-driven outcomes, so the trial will continue to event-driven outcomes, so the trial will continue for those PFS and OS readouts. So we will be able to report the myeloprotection data as well as the response rate data.

Operator

Your next question is from Ed White of H.C. Wainright.

Ed White -- H.C. Wainwright -- Analyst

I was just curious if you have any data on potential off-label use of Cosela?

Andrew Perry -- Chief Commercial Officer

We get information that has quite a significant lag on it because it has to come through claims sources. So I don't have a lot of information that pertains to the second quarter. But I would estimate a single-digit percentages of off-label use.

Ed White -- H.C. Wainwright -- Analyst

And then, Andrew, you had mentioned earlier that the majority of -- you now see a majority of live versus virtual sales calls. Maybe you could just review with us the importance of that. And do you expect this to continue going forward?

Andrew Perry -- Chief Commercial Officer

I do anticipate that it will continue going forward actually. And the big advantage, I think, and maybe on a little old school in this, but when an oncology salesperson who is competent and capable and is engaged with the product goes into an office, they're not only calling on a prescriber, they're calling on the nursing staff, they're calling on whoever channels reimbursement. We're calling on the front office staff, and they've built the colonal pharmacy, and they build up a whole picture of activities across the account, which can vastly accelerate adoption of our product. The idea of just getting to our prescriber is a very one-dimensional view of what it takes to sell any specialty product, never mind an oncology product, and there's no substitute to my mind for getting into the office and having that total call.

Ed White -- H.C. Wainwright -- Analyst

And perhaps my last question for you is just you mentioned a lot of positives going on during the launch. Wondering what sales headwinds that you're seeing and what potential solutions that you have to those headwinds?

Andrew Perry -- Chief Commercial Officer

I don't think they've really changed too much. I think it's converting the awareness of the product and the willingness to prescribe into identifying a patient. And we've been really pleased actually to see some real-world data recently presented at NCCN, where it really showed the burden of myelosuppression, which is much more profound, I think, maybe than any of us had thought, and we're starting to evaluate how we can get that into promotion because that creates a conversation about how we can do better together with the healthcare provider. And then the next part is really just shifting that kind of 20 years of habit of waiting for a problem to happen versus dealing with it proactively and getting the benefits of multi-lineage myeloprotection which only Cosela can offer.

And then finally, there's a process component, which is many of these institutions, organizations, networks are deeply embedded with an EMR system or an IT system. And the providers rely on that now for quality of care and for efficiency of care. And so working out the optimal placement for Cosela in those systems, even when you have formulary review, even when you have P&T review, even when you have enthusiastic physician support, you still need to make sure you're in those systems, and that takes a little bit of navigation behind the scenes.

Operator

Your next question is from David Nierengarten of Wedbush Securities.

David Nierengarten -- Wedbush Securities -- Analyst

Congrats on the progress here, especially on the clinical side, it's impressive. A couple of questions on the clinical side. For the ADC combination study and the bladder cancer study, I know the primary endpoint is PFS, but thinking about myelopreservation in those settings, anything we should know, there are nuances to how that will come out? Or is it going to be a straight read on neutropenia rates or things like that? And maybe another way to ask the question is, is there a significant background myelosuppression in those patients? And is it currently generally treated with Neulasta or the other agents out there? Just trying to get a feel for what we could expect for kind of background rates and effects of trilaciclib on metal preservation there.

Raj Malik -- Chief Medical Officer

Yes. So we will be looking at the outcomes of myelosuppression, so neutropenia, anemia, thrombocytopenia. Starting with Trodelvy that it does have actually quite significant rates of neutropenia. So we feel there's an opportunity there to show potential improvement, which could translate to better tolerability of the combination.

One of the things that this was actually reported at ASCO this year that efficacy of Trodelvy was associated with a greater AUC and they did an exposure response analysis looking at a Pop PK model. And so maintaining dose intensity could be important for Trodelvy. So that is something that we'll be looking at in that study. On the bladder, the chemo regimen, as you know, is GEM platinum so this includes both CIS and CARBO, and it's given a day 18 regimen schedule, I should say, which is similar to our TNBC study.

And it's going to be the same readouts that we'll be looking at. Myelosuppression does occur with those combinations as well.

David Nierengarten -- Wedbush Securities -- Analyst

Just to double check, it's a secondary endpoint, but you'll be able to track for statistically a benefit.

Raj Malik -- Chief Medical Officer

Yes. Sorry, David. Just to clarify, it is a secondary objective and there's no alpha sign. So it will be descriptive, but it will be important additional data as we evaluate myeloprotection across different regimens.

Operator

[Operator instructions] Your next question is from Anupam Rama of J.P. Morgan.

Anupam Rama -- J.P. Morgan -- Analyst

Just a question on the trilaciclib MOA study, the mechanism of action study. Kind of what's the win scenario there in your opinion? And how might that change the view of, say, Preserve 1 versus some of the efficacy studies that have been cited on this call.

Raj Malik -- Chief Medical Officer

What we've shown previously in preclinical studies as well as with peripheral blood analysis from our clinical studies is that the impact of trilaciclib is in the T cell compartment largely. So we'll be looking at effect on CD8-positive T cells, T regulatory cells, but not just the numbers by immunohistochemistry, but also sort of more functional readouts, other cells activated, which subsets are present. One of the interesting things that I think we've discussed in the past is that transient CDK4/6 inhibition can increase the formation of memory CD8-positive T cells. So that could be something that we'll be interested in looking at as well.

So it's going to be a very holistic assessment of the immune mechanism. We're also going to look at peripheral blood from these patients so we can make correlations with what's happening in the tumor with the peripheral blood. And this would, of course, help us going forward because it's much easier to look at peripheral blood going forward rather than looking within the tumor microenvironment. So if a win scenario in your terminology would really be showing that trilaciclib can modulate the tumor immune microenvironment in a variety of ways.

Operator

Your next question is from Troy Langford of Cowen.

Troy Langford -- Cowen and Company -- Analyst

Congrats on the great progress in the quarter. Just two quick ones on the Cosela launch from us. First, on the new sales initiatives. How long do you think it will take before you'll see an effect on quarterly sales? So do you think we could see an effect over a quarter or two, do you think it will play out over a longer period of time? And then I have a follow-up after that.

Andrew Perry -- Chief Commercial Officer

I think we're not in a position necessarily to provide too many predictions there. What I would say is at the account by account level, we can see rapid improvement due to execution improvements. So we'll be looking for that account by account. As to how it ladders up quarter to quarter, I don't want to second guess that at this point.

Troy Langford -- Cowen and Company -- Analyst

And then the next question I have is just, does anything in particular distinguish the last handful of top Cosela accounts that you all haven't reached yet? Do these represent bigger systems that are more difficult to break into or something else like that?

Andrew Perry -- Chief Commercial Officer

Yes. It can be a variety. So sometimes they are accounts or organizations that are completely no seal access to commercial, and they can be a mixture of academic and community in some cases. And those ones, we always knew would take longer because there's just many, many fewer shots on goal.

In some cases, it's organizations that looked at Cosela very, very early in the launch period, maybe didn't have all the information they needed. And our job there is really to get them to reevaluate the product and get more of our recent information out in front of them. And of course, these organizations, they don't like to retread. So once they've made the decision, they don't like to go back.

So getting on the docket for those decisions can take a little bit of time. We're happy we've got some plans in place across both academic and community organizations in that top 100 that have not yet adopted that we hope will continue to bear for it. And of course, those organizations are looking at their peers across the healthcare environment. And as they see more experience with Cosela and more success with Cosela, I'm sure they're going to be excited to actually have those discussions with us.

Operator

I would now like to turn the conference back to Mr. Jack Bailey for closing remarks.

Jack Bailey -- Chief Executive Officer

Great. Thank you, operator. And we look forward to keeping you updated as we progress. Thank you for joining us today and certainly hope you all stay well.

Thank you.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Will Roberts -- Vice President, Corporate Communications and Investor Relations

Jack Bailey -- Chief Executive Officer

Andrew Perry -- Chief Commercial Officer

Raj Malik -- Chief Medical Officer

Jen Moses -- Chief Financial Officer

Gil Blum -- Needham and Company -- Analyst

Kaveri Pohlman -- BTIG -- Analyst

Tony Butler -- ROTH Capital Partners -- Analyst

Ed White -- H.C. Wainwright -- Analyst

David Nierengarten -- Wedbush Securities -- Analyst

Anupam Rama -- J.P. Morgan -- Analyst

Troy Langford -- Cowen and Company -- Analyst

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