G1 Therapeutics, Inc. (GTHX) Q4 2021 Earnings Call Transcript

G1 Therapeutics, Inc. (GTHX 3.37%)
Q4 2021 Earnings Call
Feb 23, 2022, 8:30 a.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Good morning, ladies and gentlemen, and welcome to G1 Therapeutics fourth quarter 2021 financial results conference call. [Operator instructions] I would now like to turn the conference over to your host today, Will Roberts, head of corporate communications. Sir, please go ahead.

Will Roberts -- Head of Corporate Communications

Thanks, Joanna. Good morning, everyone, and welcome to the G1 conference call to discuss our fourth quarter 2021 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 fourth quarter and full year of 2021, including an update on our clinical programs and our commercial progress in that period with Cosela, which is approved by the U.S.

Food and Drug Administration 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 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 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. Any forward-looking statements represent our views as of today, February 23, 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?

Jack Bailey -- Chief Executive Officer

Thanks Will, good morning everyone. And thank you for joining us on the call. Today's headline is that the fourth quarter of 2021 was an important period of commercial transition and clinical execution for G1 that positions us well for a very important year for our shareholders, healthcare professionals, and most importantly, the patients we seek to treat. Regarding our commercial organization, Cosela is a one of a kind drug.

We are beginning to shift the paradigm from having to treat the dangerous consequences of myelosuppression resulting from chemotherapy to proactively providing multi-lineage myeloprotection, all with a single drug. There is no other drug on the market that provides that kind of protection. And I'm happy to say that we are almost fully transitioned away from our former co-promotion partner, BI, so that our G1 sales team is now in charge of executing our commercial plan and bringing this important drug to oncologists and oncology nurses across the nation. As you will hear from Andrew, we are now actively commercializing Cosela through our own G1 sales team who are now fully trained and recently deployed in their regions to drive access and uptake.

I couldn't be more pleased with the talent and the drive of this team. And I'm very proud to have them as part of the G1 organization. We have seen early encouraging signs of execution, including adding 10 top 100 accounts in the first 10 weeks by the initial seven oncology sales account managers, or OSAMs, deployed in their region. And as of the beginning of this month, we have achieved our 2021 year-end goal of trial of Cosela in 50 of the top 100 accounts.

We will continue to drive breadth, but have already begun to pivot toward driving organizational depth of use of Cosela, something that our new sales team is uniquely prepared to do thanks to their strong relationships and access to these key accounts. Our goal for the current quarter is to complete the sales team onboarding nationwide and the transition away from BI so that sales growth is reestablished as quickly as possible. Turning to our clinical operations, we made excellent progress in 2021, and expect 2022 to be an exciting year for G1. Thanks to strong execution by our clinical team.

I'm happy to announce that we are on track to share the initial data from our pivotal Phase 3 trial of trilaciclib in colorectal cancer earlier than expected, certainly no later than the first quarter, early in the first quarter of 2023. We also anticipate presenting the initial results from three Phase 2 trials later this year, one in combination with an ADC, one to confirm the mechanism of action of Trilaciclib in modulating antitumor response, and one in bladder cancer with the immune checkpoint inhibitor avelumab. Needless to say, we have a lot on which to update you on this call, I will first ask Andrew to cover our recent commercial efforts, including the status of the sales organization and some early lead measures of success from our new OSAMs. Raj will then provide an update on some of our medical and clinical momentum, including commenting on the rationale of the two new Phase 2 trials that we initiated in the fourth quarter and reminder of our expectations for timing of results.

Finally, Jen will provide the financial results for the quarter including that our cash runway takes us into 2024, then I'll be back for some concluding comments. With that, I will turn the call over to Andrew.

Andrew Perry -- Chief Commercial Officer

Thank you, Jack. I'm glad to be with you today to spend some time on a variety of commercial topics including fourth quarter sales activity, and the tailwinds we've experienced, an update and the strategic commercial decisions we made at the end of the year and how successfully we've executed on those decisions, some early impacts of those decisions and what you can expect going forward. Starting with fourth quarter sales activity, we ended the quarter with $4.4 million in net sales of Cosela representing 22% mile growth period-over-period. As we'll discuss momentarily, this growth was driven largely by some very encouraging attempt level successes by the first members of our sales team deployed at the end of last year.

However, we then experienced some slowdown elsewhere as we transitioned from BI while onboarding our new G1 OSAMs and these new patients presenting with extensive stage small cell lung cancer decreased slightly during December and January. As we've described, we exited the year with a variety of important tailwinds in our favor, including continued strong awareness and intent to use with over 85% of oncologists saying that they intend to use Cosela within the next 12 months. Positive user experience reported by our oncologists including high reorder rates and consistent feedback that Cosela fits within their clinic workflow. A growing recognition from oncologists at Cosela has a unique product profile as the only product offering multilineage myeloprotection, excellent reimbursement coverage, as a reminder, approximately 60% goes through Medicare and 30% through commercial pay and a few of the traditional payer barriers which accompany new launches.

And as you'll hear in a moment, good breadth across the top 100 target organizations and these are all important foundational elements supporting the potential acceleration in growth and account breadth and depth that we expect to drive in 2022. As I mentioned a moment ago, 85% of created oncologists intend to use Cosela within the next 12 months and over 50% within the next six months compared with an estimate of around 5% who currently are. Highlighting the great opportunity we had to drive not only breadth of uptake but also depth of share with eligible extensive stage small cell lung cancer patients, which today represent a total market value of over $700 million. The reason is most frequently cited by these oncologists for delaying trial of Cosela include limited engagement with sales reps today, and that results in a lack of education in the label, appropriate use, mechanism of action and the clinical data as well as insurance coverage.

These observations clarify why we made the strategic decision to move forward with hiring and deploying our own sales team to promote Cosela with prescribing oncologists to foster clinical advocacy and to support adoption within the office. I said in our December call that we have set a goal to hire train and deploy four regional sales directors and all 34 of our new oncology sales account managers, or OSAMs, by mid-February, and I'm happy to share that we have achieved that goal. We deployed the first seven by the end of 2021, 13 by mid-January and now all 34 are in the field a month later. In total, our new sales team brings over 500 years of oncology sales experience, and we couldn't be happier with the quality caliber and culture of this highly experienced group of professionals.

We completed their training with a live in-person sales meeting at our corporate headquarters a couple of weeks ago, and they're now actively meeting with customers to drive adoption in their therapies. Next, I'll describe some of the lead measures of success that we achieved as we began deploying our sales team and making our initial investments into penetrating some of the higher volume accounts. We ended the fourth quarter and the year with 44 of the top 100 accounts adopting Cosela, up from the 35% we had at the end of the third quarter. Since the end of the year, we've made further progress as our OSAMs were deployed and we've now achieved adoption in 50 of these top accounts.

That was a 2021 year-end goal for us and I'm enthusiastic that while we did experience some slowdown in sales at the end of the year, we were only five weeks behind where we'd hoped to be in terms of this important measure of breadth. Around 25% of the overall eligible patient population is treated within these organizations. So there's significant potential for growth as our new sales team focus on driving depth of uptake within these top accounts that are already starting to use Cosela. Around 75% of our 2021 demand came from community hospitals or clinics with the remainder being academic institutions.

Reorder rate for Cosela remains high and is accelerating in the top 100 organizations. Overall, our reorder rate for the whole of 2021 was around 75%. But if we look only at those critical top 100 organizations and focus on the most recent 13 weeks, our reorder rate has been over 80%. So the vast majority of accounts who have adopted Cosela continue to reorder and at an even higher rate in the top 100.

Importantly, we can directly correlate the activity of the first seven OSAMs deployed into priority high-potential accounts to some early, but important performance metrics. First, as I mentioned earlier, many of these new top 100 accounts that have recently come on board are the result of G1 OSAMs that have been deployed in those territories. And second, these first seven OSAMs have exceeded our expectations. Their territories were among those at the top of the nation in performance since they have been deployed.

Comparing sales in October before these OSAMs started with sales in January once they've been in the field for less than two months, vial volumes doubled in these seven territories compared with flat volumes in the rest of the country. Again, since then, we've deployed OSAMs into all sales territories. And so our goal as we move through the year is to continue to drive breadth on new high-volume top 100 accounts, but also driving depth of uptake across those clinics within those accounts. We'll accomplish this through our OSAMs to understand the account dynamics in those top 100, know how to foster our physician champions for peer-to-peer education in those accounts and can activate non-physician influencers like nursing teams.

We're supplementing those efforts with significant marketing investment and digital tools to ensure the OSAMs can take advantage of every opportunity. And in terms of what's possible in driving that, we now have several new top 100 organizations brought on board by OSAMs, which have become some of our highest ordering accounts nationwide. In some cases, that has meant vial volumes in excess of 100 or even 200 vials in just a couple of months. And yet even with this rapidity of uptake, we believe we are just scratching the surface.

This is what gives us confidence in our new direction and has energized the subsequent way of the sales team as they go into the field. Cosela is a paradigm-changing product that provides a unique benefit to patients with extensive stage small cell lung cancer undergoing chemotherapy. We believe our decision to hire and deploy our own sales team was the right decision and the early signs of success so that this decision is already paying off. Our goal in the first quarter is to complete the sales team onboarding nationwide so that sales growth is quickly reestablished.

I'm going to turn the call over to Raj for an update on our medical and clinical efforts during the fourth quarter and what to expect in 2022. Raj?

Raj Malik -- Chief Medical Officer

Thanks, Andrew and good morning everyone. I will cover two topics today. First, I will discuss each of our clinical programs with a focus on the pivotal Phase 3 trial in colorectal cancer and the updated timing of those initial results that Jack mentioned and on the two new Phase 2 trials we initiated in the fourth quarter of last year. Second, I will provide an update on some of our medical efforts, including some recently published and upcoming new data.

As you read this morning in our press release, based on the enrollment metrics we are seeing, we have accelerated the timing of the initial results from Preserve 1, our ongoing line extension trial of trilaciclib in first-line colorectal cancer. This is a pivotal trial in approximately 300 patients with colorectal cancer, receiving first-line trilaciclib or placebo administered prior to Folfoxiri and bevacizumab, an efficacious but highly myelotoxic chemotherapy containing regimen given for two consecutive days of every 14-day cycle. As a reminder, our initial preclinical data is showing the multilineage benefits of trilaciclib were generated with 5-FU, which has given as a 48-hour infusion in this regimen. Unlike most of our other ongoing trials, the primary endpoint of this trial is myeloprotection in other words, protecting the bone marrow from chemotherapy-induced damage, which results in less mylosuppressive side effects of this myelotoxic chemotherapeutic backbone.

And key secondary endpoints include progression-free survival and overall survival. Excitement at our clinical sites has been high since we initiated the study. And thanks to that and the excellent work by our team, we are projecting to announce the initial results early in the first quarter of next year, earlier than previously stated. We expect the last patient to be enrolled in the study soon, and we'll announce additional information at that point.

Next, I'll discuss the two new Phase 2 trials we initiated last quarter. Starting with the 45-patient trial designed to evaluate the additive combination potential of trilaciclib with Trodelvy, an antibody drug conjugate or ADC. Patients are being treated until disease progression on days one and eight of the 21-day cycle with trilaciclib administered prior to Trodelvy. ADCs consist of a chemotherapeutic payload that is delivered to the tumor by the antibody to which it is conjugated.

As such, ADCs can be considered targeted chemotherapy since they kill cancer cells via the cytotoxic effect of the payload. As a result, they are highly effective but can also carry a significant risk of myelosuppression. We've already shown in our Phase 2 trial that we can improve efficacy with trilaciclib, given prior to gemcitabine carboplatin cytotoxic chemotherapy in TNBC. Therefore, there could be two potential benefits of combining trilaciclib within ADC.

The first is enhancing antitumor efficacy by increasing cytotoxic killing, and the second is by reducing myelosuppression. We expect to have initial results from this trial, including overall response rate and myeloprotection endpoints in the fourth quarter of this year. The Phase 2 mechanism of action study is an important trial designed to confirm our understanding of the immune-based mechanism of action of trilaciclib and its ability to modulate the immune system with or without a checkpoint inhibitor. This trial is in approximately 30 patients who are eligible to receive neoadjuvant treatment for triple-negative breast cancer.

We know from prior clinical and preclinical data that trilaciclib has the potential to increase the ratio of CD8+ T-cells to suppressor T-regulatory cells by preferentially allowing proliferation of CD8+ T-cells while suppressing the Tregs for a longer duration. The primary endpoint will assess this ratio in the tumor microenvironment. We will also be evaluating immune changes more broadly across the cancer immunity cycle. These data should help us identify the next set of studies across multiple tumor types and treatment combinations.

Initial results from this trial are also expected in the fourth quarter of this year. In addition, I will remind you that initial results, including overall response rate and myeloprotection endpoints from Preserve 3, our Phase 2 study of trilaciclib with chemotherapy and a new checkpoint inhibitor, avelumab in first-line patients with bladder cancer are also expected late this year. This study is utilizing the same chemotherapy backbone used in our previous successful Phase 2 TNBC trial. And the immune mechanism we have generated suggests that concomitant trilaciclib could also add to the efficacy of a checkpoint inhibitor.

Finally, I'll touch on Preserve 2, our pivotal trial in triple-negative breast cancer, designed to follow up on the exciting survival signal we saw in our Phase 2 trial in that setting. We have recently made two important changes to the protocol. First, we have discontinued the second-line arm of this trial due to a shift in the treatment paradigm for second-line metastatic triple-negative breast cancer caused by the rapid uptake of Trodelvy in this setting, which has created significant barriers to enrollment in the second-line cohort of this clinical study and to the commercial potential in that setting. Second, we will allow enrollment of patients who have previously received the checkpoint inhibitor pembrolizumab for the neoadjuvant and adjuvant treatment of triple-negative breast cancer into the first-line arm of the trial to develop clinical experience in this patient population.

Initial data from this trial will be available in the second half of 2023. Changing topics to medical affairs, among the common questions that our team gets are wants regarding Health Economics and Outcomes Research, or HEOR. We've recently published two important studies on that topic. The first in the December issue of the Journal of Medical Economics describe data showing that the use of trilaciclib prior to first-line chemotherapy resulted in cost savings due to fewer myelosuppressive adverse events and their associated treatment costs in patients with extensive stage small cell lung cancer.

The estimated cost savings per patient were $18,840 from a U.S. payer perspective according to this cost-effectiveness analysis. A second recent publication in the January edition of the Journal of Managed Care and Specialty Pharmacy included the results of a study that estimated the impact of utilizing trilaciclib over a five-year period in over 300 patients. The use of trilaciclib was estimated to reduce the number of myelosuppressive adverse events, including neutropenia, fibro neutropenia, anemia and thrombocytopenia compared to a scenario without trilaciclib and was associated with the cost savings over five years of more than $800,000.

I'll conclude by mentioning that we are presenting our first real-world use data for Cosela at the upcoming NCCN Conference in March. The abstract that was accepted described compelling integral practice data for burden of myelosuppression. However, we have since added real-world data from patients who have received Cosela, most of whom are commercial patients. We look forward to sharing these data with you once they are presented.

With that, I'll turn the call over to Jen for a review of the financial results for the fourth quarter and full year of 2021. Jen?

Jen Moses -- Chief Financial Officer

Thanks, Raj, and good morning, everyone. As Will mentioned, full financial results for the fourth quarter and full year of 2021 are available in this morning's press release and will be in the 10-K, which we intend to file after market close. Today, I will focus on a few key points from our disclosures. Our total revenue for the fourth quarter of 2021 was $5.8 million, comprised of net product revenue of $4.4 million and license revenue of $1.4 million.

Our license revenue for the quarter was primarily related to clinical trial reimbursements from EQRx and Simcere. Total revenues for the full year 2021 were $31.5 million, consisting of licensing revenue of $20.4 million and net product revenue of $11.1 million from sales of Cosela. Cost of goods sold for the three months ended December 31, 2021, was $0.4 million and $2 million for the full year 2021. As a reminder, the majority 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.

These previously expensed costs will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is depleted and additional inventory is manufactured and sold. Our research and development expenses for the fourth quarter of 2021 were $19.8 million compared to $16.4 million for the fourth quarter of 2020. The increase in R&D expenses was primarily due to an increase in clinical trial spend, which is partially offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug products to support clinical trials. R&D expenses for the full year 2021 were $76.2 million compared to $73.3 million for the prior year.

Our selling, general and administrative expenses for the fourth quarter of 2021 were $23.2 million compared to $24.3 million for the fourth quarter of 2020. The decrease in SG&A expenses was largely due to a decrease in spend on commercialization activities and medical affairs when compared to our activities in preparation for launch last year and was partially offset by an increase in personnel costs due to increases in headcount. SG&A expenses for the full year 2021 were $95.7 million compared to $68.5 million for the prior year. Regarding our cash position and runway, as described in the press release this morning, we ended the 2021 year with cash and cash equivalents of $221.2 million compared to $207.3 million as of December 31, 2020.

We expect this position 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 but has not yet been drawn down. 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. Before we close the call, I want to, as always, thank people living with cancer for their inspiration. G1 was founded to discover and commercialize drugs that can inhibit progression through the cell cycle, thus improving a cancer patient's experience with chemotherapy and helping people live longer, better lives. We remain driven and focused to ensure that we reach our goals for you and your family.

Now before we move to Q&A, let me just recap some of the key points that you've heard today. We have successfully hired, trained and deployed all 34 OSAMs and four RSDs and I could not be more pleased with the quality of the team. We are already seeing evidence of the impact of the first few deployed members of the sales team on driving growth in their regions compared to regions who did not have an OSAM in place. We remain comfortable with our analysts' current expectations for Cosela net sales in 2022 with the majority of the growth happening from the second quarter of this year onward as our team establishes themselves in their regions drives adoption, breadth, focuses on account depth and then reestablishes sales growth.

Our medical team continues to present and publish important new analyses showing the clinical and economic benefits of using trilaciclib in appropriate patients with extensive stage small cell lung cancer, including the net budget impact that is estimated to be cost saving when used on label. We expect to provide initial results from three Phase 2 trials later this year, one with ADC, one on MOA and one on bladder. And thanks to strong enrollment and execution, we now expect to announce the initial results of our ongoing pivotal trial in CRC early in the first quarter of next year and perhaps sooner. This means that over the next 12 months, we expect to announce the results of four new clinical trials, including one pivotal Phase 3 line extension trial.

Thank you for your time this morning. We will speak again in this format in May on our first quarter 2022 call. With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask your questions.

Questions & Answers:

Operator

Thank you, presenters. [Operator instructions] Your first question is from Gil Blum of Needham & Company. Your line is open.

Gil Blum -- Needham and Company -- Analyst

Hi. Good morning, everyone, and thanks for taking our questions. Maybe starting with the commercial angle here. So any thoughts on potential benefits from COVID tapering in the near term? I mean, would this provide your new sales force the opportunity to meet accounts in person?

Jack Bailey -- Chief Executive Officer

Yeah. Thanks, Gil. I'll put that over to Andrew, who will make some comments on them.

Andrew Perry -- Chief Commercial Officer

Yeah. Thanks, Gil. One of the things that we do look at is the proportion of in-person sales calls each month, and that has been improving during the last month or so since the turn of the year and obviously, the downturn in omicron. Is that because of the better access that our new OSAMs have? Or is it due to omicron, it's hard to say.

But we do know anecdotally that many customers really struggled with staffing over the last few months due to omicron where staff -- if they came down with a COVID infection, obviously, we're out and had to quarantine and that does result in a decrease in capacity across an account for any type of healthcare. So it's possible that there is an impact there, but we believe we're in the -- we're doing the right thing with our OSAMs in place to be able to maximize any potential growth opportunity moving forward.

Gil Blum -- Needham and Company -- Analyst

If you have to hypothesize about the difficulties that you've had with the earlier sales arrangement, do you think it might have been -- had something to do with the incentive basis or if you had to come up with an explanation as to why it didn't work out originally.

Jack Bailey -- Chief Executive Officer

Yeah. Thanks, Gil. First of all, I would just underscore how excited we are about the 34 folks that we brought on board. I think they bring the requisite clinical knowledge and experience in proven sales performance.

I think looking back retrospectively, while we don't spend a lot of time doing that, at days then I think the key, as we talked really since June of last year is, if we can access these top 100 accounts where approximately half of all small cell lung cancer patients are being treated, what's going to be difficult for Cosela to reach its full potential. So for us, that was the real key and that's the difference we're seeing with this new sales force that Andrew has hired as they're able to get in. They've got the relationships. They've got the market understanding, the account understanding and are able to get trial.

And now really, it's about driving the depth where, again, half the patients are being treated. So hopefully, that answers your question.

Gil Blum -- Needham and Company -- Analyst

Yes, that's very helpful. Maybe a couple of clinical questions. First of all, congratulations on the accelerated time lines on Preserve. But do you have any color as to why we're seeing potentially faster enrollment or if you have any comments?

Raj Malik -- Chief Medical Officer

Hey, Gil. Raj here. Yes, I think as I mentioned, it's really two factors, right, lots of excitement in the protocol. I think it's an unmet need, and I think investigators see that.

It's an important question to test. And second is our team. Our team has really done a great job. This is a big global study and running it during pandemic is not an easy thing and really total kudos to our team for managing all the complexities of having to do that, and we're thrilled to be able to bring the timeline up.

Gil Blum -- Needham and Company -- Analyst

And Raj, while I still have you, maybe a question on the MOA study. So we are expecting a biopsy data from the study. Are we also going to be looking at serum biomarkers, things like circulating tumor DNA?

Raj Malik -- Chief Medical Officer

Yeah. We'll be looking at -- both the primary outcome will be in the tumor itself. However, we are collecting peripheral blood. And obviously, as you know, we can collect peripheral blood more frequently than we can tumor.

And so, we will be making correlations between changes in the peripheral blood to what we find in the tumor.

Gil Blum -- Needham and Company -- Analyst

All right. Thank you so much for taking our question and congratulations on a successful year.

Jack Bailey -- Chief Executive Officer

Thanks, Gil.

Andrew Perry -- Chief Commercial Officer

Thanks, Gil.

Operator

Your next question is from Kaveri Pohlman of BTIG. Your line is open.

Kaveri Pohlman -- BTIG -- Analyst

Yeah. Good morning. Thanks for the update and thanks for taking my question. My first question is for the bladder cancer study.

So I understand that the data this year would be focused on ORR. But are there any biomarkers you plan to study here because this is a broad patient population. You have cisplatin eligible, ineligible and PD-1 expressors, nonexpressors. So I guess I'm just like trying to want to understand or get some sense on your development strategy here?

Raj Malik -- Chief Medical Officer

Yeah. Hi, Kaveri. Raj here. So yes, you're right, we'll get response rate data.

This year, we'll get progression-free survival data next year, which is the primary endpoint of the study. We will be looking at our archival data for PD-L1 expression and also are looking at some peripheral blood markers as well. The primary readout, of course, is and efficacy readout.

Kaveri Pohlman -- BTIG -- Analyst

Got it. And then for the -- any -- the TNBC pivotal study, any feedback from the FDA or any sense on -- does the discontinuation of second-line TNBC cohort change anything for the first line arms, would you need to enroll additional patients or what you would have will be enough to file the NDA?

Jack Bailey -- Chief Executive Officer

Yeah, there's actually no impact of discontinuing second-line or the first-line. I mean you could -- this protocol was designed essentially as a master protocol, if you will. Each cohort, the first-line or the second-line were independently sized for those readouts. So the first-line will continue as designed.

So there's no impact of discontinuing second line on that portion of the study.

Kaveri Pohlman -- BTIG -- Analyst

Got it. That's helpful. Thank you.

Operator

Your next question is from Edward White of H.C. Wainright. Your line is open.

Edward White -- H.C. Wainwright and Company -- Analyst

Good morning. Thanks for taking my questions. So just a follow-up on the last question. Did you enroll any patients in the second-line and will we be seeing any data if you did? And also the I-SPY 2 is also discontinued just curious there to, if patients were rolled, how many? And do you expect to release any of that data even if it's only a safety data?

Jack Bailey -- Chief Executive Officer

Yeah. Hi, Ed. We did enroll a few patients. I mean not many.

So there will be some safety data, of course, that we will analyze in the second-line portion and then at some point, present that data. The I-SPY, again, just to reiterate, the reason that, that was stopped and it was actually a joint decision between us and I-SPY was really a change in the landscape with the approval of embryo added to chemotherapy in that neoadjuvant and adjuvant setting. So yes, patients, again, were enrolled. And at some point, those data would be presented as well.

Edward White -- H.C. Wainwright and Company -- Analyst

OK, thanks. And just thinking about the sales force now that you're fully staffed, I guess, as of this quarter, should we be expecting to see an uptick in expenses in the first quarter? Or for modeling purposes, is the fourth quarter really sort of the base rate that we should be expecting to see in the SG&A expense line?

Jen Moses -- Chief Financial Officer

Hey, Ed. It's Jen. I would expect an uptick in the first quarter just because if you recall, we're rolling out of the BI agreement at the end of February, and we have all of the OSAMs in this first quarter. So we would have only seen part of them in the fourth quarter.

So I would expect an increase in expenses for the first quarter. And then it should taper down after the BI arrangement is then on the -- just on the royalty base.

Edward White -- H.C. Wainwright and Company -- Analyst

Great. Thanks, Jen.

Jen Moses -- Chief Financial Officer

Yup.

Operator

Your next question is from Joseph Thome of Cowen & Company. Your line is open.

Joseph Thome -- Cowen and Company -- Analyst

Hi, there. Good morning, and thank you for taking our questions. First one on the Trodelvy combo study. I think Trodelvy alone produces a response rate around 33% with an OS of 12 months.

Is this the right comparators to use here? And maybe what improvement on those metrics would support moving forward with the TNBC combination study, which would be outside of the Phase 2. And then I've got follow-ups.

Raj Malik -- Chief Medical Officer

Hey, Joe. Raj here. Yes, so Trodelvy, we're enrolling a similar population to what they enrolled in their second, third-line study. And the response rate in the ASCENT trial was around in the 30-odd percent.

So what we would be looking for is an increase of, let's say, by about 10% or so above that as a meaningful increase. Just to remind you, from our TNBC study, we saw a small increase in response rate, a greater increase in PFS and the greatest increase in OLS. So the response rate is really just the first measure of evaluating antitumor efficacy. The PFS is in the range of around five months.

So we'd be looking, obviously from an increase, at least, let's say, about a month or so, month and a half in terms of median. So those are some of the sort of how we're going to be looking at the data when it's available.

Joseph Thome -- Cowen and Company -- Analyst

OK, great. And then maybe on the commercial performance, I know historically, you had hoped to be in a place to provide revenue guidance for 2022 around now kind of any updates there? And I know you mentioned being comfortable with analyst consensus for the year. It covers around kind of the mid-40s. Is that correct how you see it? And maybe what's the main driver to reach that goal throughout the year? Thanks.

Jack Bailey -- Chief Executive Officer

Yeah. So Joe, this is Jack. You're right we have not provided formal guidance at this point beyond what we've said is we're comfortable with where consensus said. We want to get through this transition quarter as you heard both Andrew and Jen mentioned, so that we'll get a little bit better line of sight on that trajectory.

So in terms of hitting the 46%, obviously, it really is this pivot from breadth that has been the focus of the first 12 months of the launch to now really driving depth or full organizational adoption. So we assume the breadth will continue, but really depth is the key. And we think we're fully equipped with this new sales team to be able to do that. So we're excited to have them out fully in the field, last week was our first week.

And so, we're looking forward going forward to be able to provide greater clarity to you and the rest of the focus on this audience here.

Joseph Thome -- Cowen and Company -- Analyst

Perfect. Thank you very much.

Operator

Your next question is from Tony Butler of ROTH Capital. Your line is open.

Tony Butler -- ROTH Capital Partners -- Analyst

Yes, good morning. Thanks. Raj, two questions, please. One in Preserve 1, I assume that the data that you may speak about next year would be just based upon myelosuppression.

And what I'm trying to actually get at is would it be too early to actually discuss OS and PFS would those take longer to read out. And I say this because clinical trials has a completion date at least primarily in November of '24, I believe. So that's question one. And number two, just to emphasize again on Preserve 2, eliminating the second-line TNBC.

Again, clinical trials has 250 patients. That is the same population that existed before, I just want to be clear about that. And then Jack and Andrew, two particular questions, is it real or maybe just 1, I guess, is it truly realistic to assume that you could touch 100 out of those 100 or is that -- is that very -- is that doable? Thank you.

Raj Malik -- Chief Medical Officer

So hey, Tony, it's Raj. I'll take the clinical ones first. So yes, so just to clarify, the data on Preserve 1 that we said will be available early in the first quarter would be myeloprotection and overall response rate. The later completion date that you noted in clinicaltrials.gov is really the PFS and OS data.

So just to clarify that, so thanks for asking that. And in terms of the TNBC sample size, what is currently in clinicaltrials.gov, since we just announced this today, is the combined study population of 250, which consists of 170 first-line, 80 second-line. So going forward, what we'll be enrolling is the 170 first-line to complete that cohort.

Tony Butler -- ROTH Capital Partners -- Analyst

Thank you, Raj.

Raj Malik -- Chief Medical Officer

Sure.

Andrew Perry -- Chief Commercial Officer

Yeah. Thanks, Tony. I'll jump in on the top 100. Now, obviously, as the 50 of the top 100 we have adopted today, we're really pleased to have reached that milestone for us.

But of course, that's against the backdrop of hundreds of organizations nationally that are adopting Cosela. And the scale of those top 100 varies quite a bit between the ones that who are the very largest in the country versus the ones who are in that kind of lower their sales. So I do want to make clear that this is not the entirety of the number of organizations adopting Cosela. Those are very large number of organizations nationally who are adopting Cosela and that's why you see our key headed toward debt that once we have on board a certain proportion of organizations that allow us to accelerate sales more efficiently by generating debt that's where our focus will be executionally.

So we do continue to think that additional organizations will come on board and we do have a list of top 100s that we anticipate are likely to come on board more rapidly than others, but I do want to make clear is against the backdrop of hundreds of organizations who are adopting Cosela.

Tony Butler -- ROTH Capital Partners -- Analyst

Thank you, Andrew.

Andrew Perry -- Chief Commercial Officer

Thank you, Tony.

Operator

Your next question is from Anupam Rama of J.P. Morgan. Your line is open.

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

Hi, guys. Thanks so much for taking the question. I have a broader strategic question actually. There's, a lot of studies with trilaciclib going on looking at ORR, PFS, OS, understanding the infant tumor benefit of trilaciclib.

Is there any thought on taking on some indications that are more like, say, small cell where you enhance the myelopreservation benefit, thus enhancing the chemo benefit in like you have with the small cell label? Thanks so much.

Jack Bailey -- Chief Executive Officer

Yeah. Thanks, Anupam. Appreciate it. I do think that the CRC is an important one in terms of being able to tap into our market, a tumor type that is five to six times the size of small cell.

So we certainly look forward to getting that data. You're correct that we have pivoted over the last 18 months to more on the antitumor efficacy. Doesn't mean that we won't ever continue to do myelopreservation studies -- and in fact, the AGC combination study actually taps into both. So I think for us, we'll continue to look at both.

We will design smart trials like the team has tried to do to-date. And we'll certainly follow the science where it goes as we've seen with the changing regimens and some of the new things coming out. But I would say both are on the docket as reflected in our current development plan. And going forward, we'll continue to monitor both to see where we can benefit patients the most and stay on the crest of the sciences.

Thanks. Hope that answers your question.

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

Thanks so much.

Operator

Your next question is from the line of David Nierengarten of Wedbush Securities. Your line is open.

David Nierengarten -- Wells Fargo Securities -- Analyst

Thanks for taking the question. Maybe it's a different flavor of Anupam's question. But let's -- looking forward, let's say that you show or you're able to show myelopreservation benefit in triple-negative breast cancer, for example, but maybe you don't quite hit statistical significance on PFS? Is there a scenario that combined with that second -- with the secondary endpoint of myelopreservation and the colon cancer study that you could maybe address a broader label or have a broader label for myelopreservation in all tumor types is there any precedent for that? I mean I know Amgen, I believe, had three different tumor types to get the broader label for Neulasta? Is it possible, do you think to go to the FDA with a secondary endpoint win on that, get a broader myelopreservation label and then maybe address some other tumor types or is that too much speculation?

Jack Bailey -- Chief Executive Officer

Yeah. It's not an uncommon question to your point, David, given how we've seen certain therapies in the oncolytic space progress. So, and certainly we will keep the discussions open with the FDA as we get the readouts on these additional studies. I would also add that at day's end, through things like compared to your listing, right, you can also see payers be willing to reimburse as the data repository grows on, you see either in myelo or an antitumor efficacy.

So I don't have much clear of an answer than that. We do want to pursue it, but we also know that at days end we sort of take this product by product indication by indication.

David Nierengarten -- Wells Fargo Securities -- Analyst

And then maybe a quick follow-up, do you feel that the competitive profile, again, if that scenario were to play out, that the competitive profile of trilaciclib would be sufficient to compete against the other agents if you had a myelopreservation label.

Jack Bailey -- Chief Executive Officer

I just want to make sure I understand, will we be able to compete on the myelopreservation side?

David Nierengarten -- Wells Fargo Securities -- Analyst

So in other words, yes, do you think you could displace the other agents with solely a myelopreservation label in different tumor types, if that were to play out or do your payers and doctors look for more?

Jack Bailey -- Chief Executive Officer

I think from what we've seen both from payers to-date and from the providers who have adopted early on is they appreciate the fact that you're able to prevent myelosuppression and you're able to do it with one product rather than multiple. So I don't envision that either payers or providers as the data grows on that, that that's going to be something that they don't appreciate, I'll put it that way. So I think it's really going to come down to the data, but we are pursuing both antitumor efficacy and myelosuppression and in some cases, both, as I mentioned, in the ADC combination study. And I think that the data grows, hopefully, what we've seen initially from payers is they really like this product because of the cost savings and providers like it because of what it represents in terms of patient benefit.

So hopefully, as the data readouts continue, that will be the case going forward.

David Nierengarten -- Wells Fargo Securities -- Analyst

Got it. Thank you.

Jack Bailey -- Chief Executive Officer

Thanks, David.

Operator

[Operator instructions] Your next question is from Bowen Wu of Raymond James. Your line is open.

Bowen Wu -- Raymond James -- Analyst

Good morning, guys. This is Bowen on for Dane. Thanks for taking our question and congrats on the quarter. Just on trilaciclib on a higher level, what do you think it will take to kind of get a tumor agnostic label? And then on the colorectal trial, whether you guys kind of seeing or expecting to see an initial readout for Preserve 1? Thank you.

Jack Bailey -- Chief Executive Officer

OK. I'll take the tumor agnostic question, and then I'll flip it over to Raj in terms of expectations on CRC. Yes, I think these last three questions, and are all similar in that as these data readouts come, right, that does grow the repository of evidence in terms of being able to use trilaciclib either for more tumors on the myelopreservation front or as the data comes out and in tumor efficacy. Certainly, we would like to make sure that -- we progress in that.

That's our vision is that there is a tumor-agnostic vision for this asset. We think the benefit of either myelopreservation or antitumor efficacy or in some cases, both ought to be available to the appropriate patients, but we want to make sure we've got the data there. But that's certainly our aspiration and it's what we're pursuing with our development plan. I think we've got a way for the readouts.

But that's certainly why we've designed it like we have. In terms of the CRC, I'll flip it over to Raj.

Raj Malik -- Chief Medical Officer

So it's going to be the data early next quarter. Not next quarter, early 2023, I should say, will be myeloprotection data and response rate data. So that's how we'll be available. And so the endpoints are similar to what we studied in small cell lung cancer.

So the duration of severe neutropenia, occurrence of severe neutropenia and also we're evaluating patient-reported outcomes. So those will be available as well in addition to response rate.

Bowen Wu -- Raymond James -- Analyst

Thank you.

Jack Bailey -- Chief Executive Officer

Thank you, Bowen.

Operator

Thank you. I am showing no further questions at this time. I would like to turn the conference back to Jack Bailey.

Jack Bailey -- Chief Executive Officer

Thank you, operator. As always, we appreciate you joining today. We look forward to keeping you updated on our progress. And again, thank you for joining us today, and please stay well.

Thank you.

Operator

[Operator signoff]

Duration: 52 minutes

Call participants:

Will Roberts -- Head of Corporate Communications

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

Edward White -- H.C. Wainwright and Company -- Analyst

Joseph Thome -- Cowen and Company -- Analyst

Tony Butler -- ROTH Capital Partners -- Analyst

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

David Nierengarten -- Wells Fargo Securities -- Analyst

Bowen Wu -- Raymond James -- Analyst

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