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G1 Therapeutics, Inc. (GTHX) Q4 2020 Earnings Call Transcript

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GTHX earnings call for the period ending December 31, 2020.

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G1 Therapeutics, Inc. (GTHX -1.39%)
Q4 2020 Earnings Call
Feb 24, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Ladies and gentlemen, thank you for standing by, and welcome to G1 Therapeutics Fourth Quarter 2020 Financial Results Conference Call. [Operator Instructions]

I would now like to hand the conference over to your speaker host today, Will Roberts, Head of Investor actions at G1 Therapeutics. Please go ahead.

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

Thank you, Lydia. Good afternoon, everybody, and welcome to the G1 conference call to discuss our fourth quarter and full year 2020 financial results and business update. The press release on these financial results was issued after market closed this afternoon and can be found in our news section of our corporate website, g1therapeutics.com. On this afternoon's call, the team will provide an overview of the fourth quarter and full year 2020, including an update on our launch progress with COSELA, which was approved by the U.S. Food and Drug Administration on February 12, 2021, 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'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 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 24, 2021. Joining me on the call today are Jack Bailey, our Chief Executive Officer; Raj Malik, our Chief Medical Officer; Soma Gupta, our Chief Commercial Officer; and Jen Moses, our Chief Financial Officer.

I'll now turn the call over to Jack Bailey, our CEO. Jack?

Jack Bailey -- Chief Executive Officer

Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. We hope that you and your families are well. Today's headline is that G1 is a very different company than it was a year ago or even last quarter. Only eight days ago, we were on the call with you to announce the FDA approval of COSELA, the first and only FDA-approved therapy that is administered proactively to deliver multi-lineage myeloprotective benefits to patients with extensive stage small cell lung cancer. The entire G1 team is energized to be making this important therapy available to cancer patients, but of equal importance is our rapidly evolving clinical pipeline, intelligently designed to help address the unmet needs of people with a variety of different cancers, who require a ray of chemotherapies. We are initiating and conducting the clinical trials evaluating COSELA across an array of cancers and chemotherapy regimens. Within the first half of 2021, we expect to have two registrational trials under way: one in colorectal cancer, in which we began dosing patients last month; and another in metastatic triple-negative breast cancer, which will initiate in the first half of this year.

We will also have three Phase II studies under way. These include our IFY two neoadjuvant breast cancer trial, which was initiated last year, and as we announced in January at the JPMorgan Conference, we expect to initiate Phase II trials in both non-small cell lung cancer and bladder cancer in the first half of 2021, with each study having antitumor efficacy as the primary endpoint. Regarding the bladder cancer trial, we announced an important supply agreement with Merck KGA of Darmstadt, Germany and Pfizer in our press release this afternoon, which Raj will describe in more detail. G1 was founded with a sole purpose of making a difference in the lives of people living with cancer. The launch of COSELA is the first step. We believe that COSELA will be an important therapy in the arsenal for improving lives of patients with a variety of cancer diagnosis as we work toward the goal of developing it as a tumor-agnostic solution for patients with cancer. And it also represents an excellent opportunity to bring strong value to our shareholders. This is a transitional call for us, given that we are only a few days past turning the corner to becoming the commercial organization and just a few days past our last call with you all on the commercial launch readiness. So while Jen will cover our financial results for the fourth quarter and full year 2020 toward the back end of the call, the rest of the call will largely be forward-looking. I will ask Raj to cover our clinical focus with COSELA, including a reminder of a mechanism of action, which we believe will be broadly applicable. Soma will then briefly provide an update on some of our launch efforts over the past eight days, including the ongoing launch meeting being held this week. Then I'll be back for some concluding comments.

I'll now turn the call over to Raj for an update on COSELA in the clinic. Raj?

Raj Malik -- Chief Medical Officer

Thanks, Jack, and good afternoon, everyone, on quotes on the call with us. This is a very exciting time at G1 as we are in the process of launching COSELA for patients with extensive stage small cell lung cancer and at the same time, developing it in the clinic for a variety of other solid tumors. Over the past few weeks, there has been considerable interest in the single mechanism, potential dual benefit of COSELA. So I want to take some time this afternoon to walk you through it as it will help to clarify the educated approach that we are taking to determining the cancers to pursue in the clinic. COSELA is administered as a 30-minute intravenous infusion completed within four hours prior to the start of chemotherapy. It has a single mechanism of transient G1 cell cycle arrest due to transient CDK46 inhibition in susceptible host cells, which temporarily blocks progression of feed cells through the cell cycle. In cancers like small cell lung cancer, chemotherapy is highly myelosuppressive and given multiple days in a row. Chemotherapy is an essential treatment for most tumors, but it kills proliferating cells indiscriminately causing damage to tumor cells and host cells like hematopoietic stem and progenitor cells, or HSPCs alike. COSELA transiently arrests the HSPCs in the G1 phase of the cell cycle, thereby protecting and preserving Myelo cell lineages like neutrophils and erythrocytes, and lymphoid cell lineages like T&B lymphocytes from the myelosuppressive damage caused by chemotherapy. The half-life of COSELA is relatively short, approximately 14 hours. And as a result, the HSPCs quickly recover and start to produce mature blood cells. This model protection benefit was conclusively demonstrated in our three double-blind placebo-controlled trials in extensive stage small cell lung cancer, which led to the approval of COSELA by the FDA to decrease the incidence of chemo-induced myelosuppression in patients with extensive stage small cell lung cancer.

We are also exploring whether COSELA has the potential to improve antitumor efficacy through a combination of factors: one, through the protection of the immune system, allowing it to function after chemotherapy; and two, by enhancing anti-tumor immune response by increasing the ratio of effector CD8-positive T-cells to immunosuppressive T-regulatory cells, which is important to immune priming, by directly activating CD8-positive T-cells to improve T-cell-mediated response and by increasing clonal expansion of T-cells. In addition, COSELA may increase the patient's ability to receive a longer duration of chemotherapy, and as such, can also contribute to improving antitumor efficacy. COSELA appears to activate a T-cell mediated immune response with clinical evidence of improved antitumor efficacy when the tumor is immune responsive. This benefit was shown in the clinical data from the triple-negative breast cancer Phase II trial, which we presented in December at the 2020 San Antonio Breast Cancer Symposium and was previously published in the Lancet Oncology. This randomized open-label Phase II trial of COSELA in combination with gemcitabine and carboplatin, a current standard of care for metastatic triple-negative breast cancer, enrolled 102 patients who had received up to two prior chemotherapy regimens for locally recurrent or metastatic triple-negative breast cancer. In this 3-arm trial, all three groups received a chemotherapy regimen of gemcitabine and carboplatin. Patients are randomized to receive either gemcarbo only in group 1. Gemcarbo plus COSELA administered on the day of chemotherapy, Group II for Gemcarbo plus COSELA administered the day prior to and the day of chemotherapy, Group III. The survival results were pretty remarkable and compared to Gemcarbo alone, overall survival was significantly improved in both COSELA arms.

And importantly, patients with both PD-L1 positive and PD-L1 negative tumors treated with COSELA prior to their Gemcarbo, demonstrated improvement in OS compared to patients receiving Gemcarbo alone with the PD-L1 positive subset achieving statistically significant improvement. We will initiate a registrational trial in patients with metastatic triple-negative breast cancer in the first half of this year to evaluate COSELA in combination with the chemotherapy regimen of Gemcarbo in two separate cohorts. As first-line treatment in 170 patients who are filed checkpoint inhibitor treatment naive and as second-line treatment in 80 patients whose disease has progressed following prior checkpoint inhibitors. Both cohorts are adequately and independently powered and we will provide more information on trial design when we announce initiation of this trial. Another thing we have learned is that the best place to see the bioprotection benefit I discussed earlier is in chemotherapeutic regimens that require administration of chemotherapy on multiple days in a row. That leads us to our approximately 300-patient registrational trial in colorectal cancer, which began enrolling patients in January. In this trial, patients received Folfox Erie and bevacizumab, the most efficacious chemo regimen in colorectal cancer, but also the most myelosuppressive. Patients receiving [Indecipherable] are administered irinotecan, oxaliplatin and bevacizumab on day one and then a continuous infusion of 5-FU over 48 hours starting on day 1. After 12 2-week induction cycles with all chemotherapy agents, 5-FU and bevacizumab are continued in maintenance until disease progression. Patients will receive COSELA or placebo prior to chemotherapy on day one and again on day two during the 5-FU infusion with every cycle during induction and maintenance.

The primary endpoints for myelo-protection include duration of severe neutropenia in cycle one and occurrence of severe neutropenia, and the secondary endpoints include progression-free survival and overall survival and patient-reported outcomes. 80% of the alpha is reserved for the myeloprotection endpoints, but we have reserved 20% of the alpha for the antitumor efficacy endpoints. We expect the data readout in the first half of 2023. In addition to those registrational trials, we announced in January that we expect to initiate two additional Phase II trials of COSELA in known immunogenic tumors in the first half of this year. The first is a randomized open-label trial in first-line locally advanced or metastatic bladder cancer also called locally advanced or metastatic urothelial carcinoma. COSELA will be administered prior to gemcitabine platinum chemotherapy, which is a similar regimen to the one we used in the triple-negative breast cancer trial followed by maintenance therapy of COSELA in combination with the checkpoint inhibitor avelumab until disease progression. To that end, we were happy to announce this afternoon in our financial results and business update press release that we have entered into a clinical trial collaboration with Merck KGAA, Darmstadt, Germany and Pfizer, whereby the alliance will contribute clinical supply of avelumab and to this first-line metastatic urothelial carcinoma trial. The primary efficacy measure of the trial is antitumor efficacy, and we expect to have initial data in late 2022. The second is a randomized double-blind Phase II trial in second-line and third-line patients with non-small cell lung cancer who have progressed following checkpoint inhibitors. Patients who received COSELA or placebo prior to each administration of docetaxel. The primary efficacy measure of the trial is, again antitumor efficacy, and we expect interim data in the first half of 2023.

We also intend to support a variety of investigator-sponsored studies starting this year. We opened our online portal to receive requests for investigator-sponsored studies late in 2020, and the interest has been strong. We expect these to be small open-label studies with quick data readouts, so you can expect a consistent cadence of data. We will keep you updated as the investigator-sponsored studies get up and running. I want to touch briefly on our Oral SERD rintodestrant as well. The mature monotherapy data from our Phase Ib trial in a heavily pretreated population of ER-positive HER2-negative patients were presented at the 2020 San Antonio Breast Cancer Symposium confirming the results of the preliminary analysis. We reported good safety and tolerability, which is important for an oral SERD. We also saw robust target engagement at a clinical benefit rate, or CBR, of 30% in the ballpark of what is seen with other oral SERDs. We advanced an 800-milligram dose of rintodestrant into a phase patients who are somewhat less heavily pretreated than those in the Phase Ib. Enrollment was completed in October 2020, and we expect to announce initial safety and efficacy results in the second quarter of 2021.

With that, I'll turn the call over to Soma for her update on the first couple of weeks of the COSELA launch. Soma?

Soma Gupta -- Chief Commercial Officer

Thanks, Raj, and good afternoon, everyone. Thanks for joining us on the call. These are exciting and very busy times as we are commercially launching COSELA, completing the training of our field force and generating broad interest as we prepare for product availability in the coming days. We provided a very robust update just a few days ago on our approval call to today's prepared comments will be fewer and focused on what we've accomplished in the last week-or-so. I will first briefly comment on our baseline awareness per [Indecipherable]. G1 conducted a series of surveys over the past several months to a cycle varies and interest and usage, and we will continue to do so going forward. Based on our final pre-approval survey, awareness trends have continued to go our way. The sample of 75 physicians with a 70% community, 30% academic split, aided awareness is at 50%, which is a significant jump from 30% in November and is in line with what we would expect from similar benchmarks in this space. Also, the percentage of oncologists who are engaging in prophylaxis for some portion of their patients, what we think of as providers who will be most receptive to the COSELA proactive protection message has increased from 66% in June of last year to 77% today, likely driven at least in part by heightened sensitivity in the COVID-19 pandemic environment. We were also glad to see the latest metrics for our myelosuppression disease state education campaign indicate that 30% of our Tier one to three targets have engaged with the content. As many of you know, this is well above the expected benchmark of 8% to 10%, suggesting that this is a topic providers have interest in learning more about. Interestingly, our survey data also indicates a steady increase in unaided mentions of non-neutropenia related concerns of PNO-induced myelosuppression, likes for anemia and dose reductions or delays, more than a doubling from prior to the campaign and even higher if U.S. nurses, all in all, a good foundation on which to launch for cell.

As of day one, the COSELA approval, which was February 12, the field for, including our GPO account managers, clinical nurse educators, our national accounts team, managed markets and the bringing home sales reps have begun their outreach to set up appointments with our Tier one cargo providers. Detailing on presentations will start immediately after our reps are certified as of the end of this week. I'm happy to confirm drug is planned to be in channels around this time also as we are on target for March 2. Our MSLs have been engaging with positions for months in peer to peer discussions about the multi-lineage impact to myelosuppression and have now added the approval of the product to their conversations. So far, the early anecdotal feedback has been very positive. For example, one community provider told us that this is exactly what we want to see in our practices and to know that giving this drug can save patients from adverse events and hospitalizations. Similar positivity from payers has included comments like the following from a national plan Medical Director who said, "I applaud G1 for finding a way to achieve one therapy to address myelosuppression as opposed to multiple treatments we use now." This is just a sampling of the positive feedback we have received thus far. Also, since approval, our GPO account directors indicate several of the large community practices already taking initial steps to get trilaciclib reviewed and added to formulary. Our launch sequence has been very intentional, and the activities for days one through seven on approval support the goals of: first, getting our NTCN submission in to get COSELA quickly added to the guidelines; second, completing all pricing compendious submissions to enable reimbursement, ordering and flow treatment guidelines into EHRs; and third, getting the sales team certified on the label and on core marketing materials. Regarding NCCN, Raj's medical affairs team has already completed our formal NCCN submission.

We hope to see COSELA added to the guidelines in a few months. Regarding the pricing compendia submission, our market access team has submitted to all pricing compendia, and medical affairs team has submitted to all other clinical compedia as well. Regarding the sales team, it completed their initial training on the label last week. Today is day two of the 4-day COSELA launch meeting, which had a strong emphasis on training and practice workshops. It is important to clarify that we are doing this launch meeting remotely and virtually with a socially distance sat at adherence to COVID-19 mitigation procedures. Despite gain in a virtual setting, this launch meeting has all the had mix of traditional and personal one, including training such as on various topics, such as MOA, package insert and the core interactive sales aid. There will be exercises focused on effectively overcoming objections, education panels featuring HCPs and oncology nurses, and inspirational sessions devoted to patient journey caregiver stories. In parallel, we are also activating a robust branded digital campaign to drive awareness and augment the sales force efforts. At the end of this program, every rep will be fully trained, certified and ready to sell in person where possible, virtual were needed or preferred early next week with product and channel ready to order on March 2. The team has already started to invite our target physicians, nurses and pharmacists to our upcoming national broadcast. Some of the most experienced oncologists will educate their peers on the impact of chemo induced myelosuppression and COSELA clinical trial data at this session. The national broadcast is scheduled for March 25 with an Encore on the 26th.

The broadcast will include a panel presentation and discussion with Dr. Ed Kim, Vice Physician and Chief at City of Hope National Medical Center, Dr. Mohammad Mohammad, Director of Thoracic Oncology at Cone Health Cancer Center; and Dana Herndon, a thoracic oncology nurse also at Cone Health. It is probably worth reminding folks at about 1,500 first-line small cell lung cancer patients are triggered each month across the country. We expect COSELA to be considered for use in newly incident patients versus the pent up demand we might see for therapeutics. We, therefore, expect this to be a steady climb over the first few months were providers first born about COSELA, then find an appropriate patient and soon to gain some experience and then move it into their practice more broadly. All of this to say that by beginning of next week, we'll be fully teed up with branded COSELA marketing materials to actively promote COSELA and supporting [Indecipherable] oncologists, oncology nurses and payers. We expect the entirety of our field force to communicate the advantages of COSELA with materials in hand and products and channel, ready to improve the chemotherapy experience of small cell lung cancer patients. It's a very exciting time for both the commercial teams at G1 and BI.

And with that, I'll turn the call over to Jen Moses. Jen?

Jennifer Moses -- Chief Financial Officer

Thanks, Soma, and good afternoon, everyone. As Will mentioned, full financial results for the fourth quarter and full year 2020 are available in our press release and 10-K. Today, I'd like to focus on a few key points from our disclosures. License revenue for the fourth quarter of 2020 was $16.5 million, primarily related to an upfront payment or a license agreement with sincere, which provides them with development and commercialization rights for trilaciclib across all indications in Greater China. This payment was recognized following the transfer of the related technology and know-how, which occurred during the period. In addition, we recognized revenue for existing inventory transfers related to our license agreements with Genor and EQRX for lerociclib as well as revenue for reimbursable clinical trial costs due from EQRX. License revenue for the full year 2020 was $45.3 million. G1's research and development expenses for the fourth quarter of 2020 was $16.4 million, down from $24.5 million for the fourth quarter of 2019. The decrease was primarily due to a decrease in clinical program costs, external costs related to discovery and preclinical development and costs for manufacturing pharmaceutical active ingredients. We expect our clinical program costs to increase as we initiate our two new Phase II trials and our registrational trial in TNBC later this year. Our general and administrative expenses for the fourth quarter of 2020 were $24.3 million, double the $12.1 million in the fourth quarter of 2019. As would be expected, the increase was largely due to an increase in compensation due to additional headcount and increases in pre-commercialization activities medical affairs costs related to preparing the company and the market for the launch of COSELA. We ended the year with cash and cash equivalents of $207 million, slightly above our year-end cash guidance of $200 million to $205 million. Subsequent to the reporting period, between January 14 and February 9, 2021, and we sold 3,513,027 shares of common stock pursuant to our 2018 sales agreement for aftermarket offerings with Cowen & Company, resulting in $86.4 million in net proceeds. This activity utilized all remaining capacity under the sales agreement. So this ATM offering is now closed. Also, the company now has access to $30 million of the remaining $80 million of our debt financing facility with hercules capital upon achievement of the FDA approval of COSELA milestone. We now expect our current financial position to be sufficient to fund operations into 2023. With that, I'll turn the call back over to Jack. Jack?

Jack Bailey -- Chief Executive Officer

Thank you, Jen, Soma and Raj. Before we close the call, I want to underscore that without the participation of people living with extensive stage small cell lung cancer and their families, doctors, nurses and caregivers, we would not be making COSELA available today. We are grateful for their support and humble to be part of your community. We will work hard every day to improve the chemotherapeutic experience of people living with extensive stage small cell lung cancer. Now as I mentioned at the start, we are a very different company than we were a year ago or even a quarter ago. Our first product COSELA is approved and will soon be available for patients living with extensive based small cell lung cancer. We are developing a broad and growing clinical pipeline of intelligently designed trials across an array of cancers and chemotherapeutic regimens with both myeloprotection and antitumor efficacy endpoints, to deliver on our tumor-agnostic vision for COSELA, with the additional $86 million from our at the market, which is now closed, we believe that our cash runway will take us into 2023. This ATM offering has provided us with the capital that we believe we need to run the company. And as such, we have no plans for any additional offerings in the near term, and we have a team of experienced professionals throughout G1 solely dedicated to bringing new therapies to cancer patients who need them. This all gives me the confidence as we turn the corner to commercialization, while at the same time, advancing the development of COSELA in a tumor-agnostic matter. As we proceed with commercializing COSELA, we will be open to transparent to help you track our performance. While we will not be providing revenue guidance for 2021, we will consistently provide you with both qualitative and quantitative metrics of both leading and lagging indicators of interest and uptake, along with our revenue results every quarter, starting with the results of the current quarter.

With that, I'll close the call and turn it over to Q&A. Operator, would you please remind our listeners how to ask a question.

Questions and Answers:

Operator

[Operator Instructions] Our first question coming from the line of Ed White with H.C. Wainwright. Your line is open.

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

Alright. Thanks for taking my question. Maybe just start off with a couple of questions for Jen. That last $50 million from Hercules, what is the trigger for that to become available and is that $80 million that's available included in the guidance for cash to last through 2023?

Jennifer Moses -- Chief Financial Officer

Yes. Thanks, Ed. The full $80 million is not included because we have the ability to access the $30 million, I'm including that in the guidance into 2023. To access the additional portion of the Hercules facility revenue based for $30 million of it and the additional $20 million is at their discretion. We expect to meet additional milestones later in this year.

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

Great. Thank you. And then a question for Soma, just one thing you had mentioned was that non aided patients had concerns over myelosuppression. I'm just wondering if you have plans for any DTC advertising?

Soma Gupta -- Chief Commercial Officer

Yes, sure. Sure, happy to take that. What we actually think, because small cell is an urgently presenting disease, broad-based DTC for small cell probably doesn't make sense, but what we do think is critical is working with advocacy. We've actually been doing quite a bit with CO2 foundation and longevity because we think that what will happen is once they get a diagnosis, they will very quickly seek out the major advocacy organizations to get their information. We actually think that that's the best way to get that in their hands versus big DTC, which obviously can be a significant expense, but more importantly, probably won't get to them at the time that they actually need to make the decision. We're being very targeted about it. We are doing some digital consumer things. But in general, we do think advocacy has the greatest role to play here, just given the urgency of the diagnosis and how quickly they go on to treat them.

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

Great. Thank you. And then my last question is for Raj. Just you gave great guidance over the timing of data for some of the trials. I'm just wondering if you can give us some thoughts on timing for data for the triple-negative breast cancer trial and also the bladder cancer? Thank you.

Raj Malik -- Chief Medical Officer

Yes. Hi, Ed. For the TMBC, it will be the second half of 2023 and for the bladder cancer, we expect initial data later next year, toward the end of 2022.

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

Okay, great. Thank you very much for taking my question.

Operator

Our next question coming from the line of Chad Messer with Needham. Your line is open.

Chad Messer -- Needham -- Analyst

Great. Thanks for taking my question. Maybe to start, as you're out there preparing to bring this drug to patients, is there a profile that you think doctors have for the initial patients, they might try to get this on maybe by risk factor or line of treatment or something like that or or do you think kind of first available as of March 2nd?

Jack Bailey -- Chief Executive Officer

Yes. Thanks, Chad, for that question. I really think because of the profile and the benefits that COSELA brings, really any patient who's got extensive stage small cell lung cancer is really the target, and we talk about the first time every time they get put on chemotherapy. Given that every patient in that first-line regimen that we studied and have in our label get those benefits, both in terms of the reductions in levels, but also feeling better, we believe that ultimately, it's not a question of parsing out patients, but rather, it's really every patient the first time every time who's got extensive stage small cell lung cancer.

Chad Messer -- Needham -- Analyst

Yes. No, I think given all sell is like that makes sense. And perhaps just one on the rent data that's coming up. Can you help us benchmark what good efficacy based on sort of the competitive landscape would look like in combination with Palbo?

Jack Bailey -- Chief Executive Officer

Go ahead, Raj.

Raj Malik -- Chief Medical Officer

Yes. Chad, Raj here. Yes. So in this 40-patient dataset where into was combined with Palbo, the patient population so that's heavily pretreated compared to our monotherapy dataset. And closer to the population that was enrolled in the Paloma three trial. At that trial, the clinical benefit rate at six months was 64%. What we will be looking for is continued good safety and tolerability. The profile we saw as a monotherapy and a CBR rate in that 60% to 65% range.

Chad Messer -- Needham -- Analyst

Alright. Great. Thank you. It's very helpful.

Jack Bailey -- Chief Executive Officer

Welcome.

Operator

Our next question coming from the line of Phil Nadeau with Cowen. Your line is open.

Phil Nadeau -- Cowen -- Analyst

Good afternoon. Thanks for taking my question. A couple on the commercial side. You mentioned compendia that submissions have been made. Can you remind us, are some compendia more important than others? Which are the ones that are particularly influential?

Jack Bailey -- Chief Executive Officer

Soma, can you handle that, please?

Soma Gupta -- Chief Commercial Officer

Yes. Sure. So obviously, companion is a pretty broad category of things. I think NCCD is a compendium of itself. That is clearly the gold standard. There are additional ones, though, that are in the mix that drive pathways for kind of whether the larger GPO type of environment and those are ones that we have submitted to on the clinical side. And then on the payer -- on the kind of more payer access side, things like Micromedex Lexidrugs. Things like that, we've also submitted to so that they can sort of flow into through the EHR systems. There are multiple different ones and we're actively pursuing each one, but NCCN is the go-to guide for compendia. And while it is very influential on the other pathways, I guess, is the best way to put it.

Phil Nadeau -- Cowen -- Analyst

Got it.Okay. That's very helpful. And in terms of NCCN specifically, do they post meetings where they come to determinations or is there a defined protocol that they work through as they're assessing new drugs or is it more on the fly just as drugs are available, they tend to consider them?

Jack Bailey -- Chief Executive Officer

Yes. I going to let Raj to answer that.

Raj Malik -- Chief Medical Officer

Yes. So yes. So the -- we submitted the -- the applications to both the small cell lung cancer and the Hemorrhagic Pleural growth factor guideline committees. Typically, what they will do is with new drug approvals, they will meet whatever they're able to pull the guideline committees together and review the evidence. That's why we think it would take a few months and -- but they often do that outside of the regularly scheduled meetings, which occur annually.

Phil Nadeau -- Cowen -- Analyst

Got it. And maybe last question for Soma. Before the NCCN comes out, it's utilization likely? I guess, how closely do your physicians and practices adhere to the NCCN guidelines? Will they adopt new medicines prior to the guidelines? Or is it similar to the ACIP recommendation for a vaccine, where the NCCN guidelines are a major catalyst for uptake?

Jack Bailey -- Chief Executive Officer

Yes. Phil, this is Jack. Thanks for the question. We won't get some utilization prior to NCCN, but that is an important point or catalyst to Soma's earlier point, as that triggers the regional pathway organizations and it enables a lot of times organization so then get it in things like order set, but you will get some utilization. It's just -- it's a very helpful endorsement obviously in the oncology space to get them to endorse it. And as Raj said, we're probably a couple of months until we get that.

Phil Nadeau -- Cowen -- Analyst

Perfect. Thanks for taking my question and congratulations on the progress.

Jack Bailey -- Chief Executive Officer

Thanks, Phil.

Operator

Our next question coming from the line of Tony Butler with ROTH Capital. Your line is open.

Tony Butler -- ROTH Capital. -- Analyst

Yes. Raj, I want to just touch on the trial in bladder cancer with Avelumab. And I wanted to understand, would the trial actually mimic Javelin 100? That's effectively the first question. And secondly, the key is do you actually utilize COSELA during the -- because you do have first-line platinum chemo before you actually put Bavencio on top with respect to maintenance. Do you actually put COSELA onboard just during the chemotherapy phase, and then it stops as Avelumab comes on board? I just want to clarify. Thanks.

Raj Malik -- Chief Medical Officer

Yes. Tony, yes, you're absolutely right. Javelin 100 is sort of the model, if you will. I mean, that's the standard with Avelumab maintenance following up to six cycles of Gem platinum therapy. Our trial is going to include COSELA administered with the chemotherapy and with the Avelumab maintenance with the control arm being, of course, just the chemotherapy alone and the value-add maintenance. Essentially, it's an add-on to that standard of care.

Tony Butler -- ROTH Capital. -- Analyst

That's great. And then, again, if I may, the readout is overall survival, is that fair or is there a PFS readout? I'm asking what in effect would be the primary?

Raj Malik -- Chief Medical Officer

Yes. So we'll provide more details on that, Tony, when we describe the trial, but these will all be antitumor efficacy readouts with the initial readouts being toward the end of next year, as I mentioned, which will likely be more response rate focused that others to follow.

Tony Butler -- ROTH Capital. -- Analyst

Thanks, Raj. Appreciated.

Raj Malik -- Chief Medical Officer

Sure.

Operator

Our next question coming from the line of Dane Leone with Raymond James. Your line is open.

Dane Leone -- Raymond James -- Analyst

Thank you for taking the question. Congratulations on the launch, and thank you for providing the details around that. I just wanted to ask more of a strategic question. When we think about the company going into the launch of trilaciclib and potentially expanding indications over the next couple of years, how do you think about other assets around that, that, I guess, you may think about acquiring externally or bringing in -- do you view G1 Therapeutics as focused more on supportive care for oncology at this point, and that's where the synergy would be with the channel that you're building or would you also look at more traditional assets that would be directly targeting the tumors as well? How are you thinking about the company's strategy as it's kind of changing right now?

Jack Bailey -- Chief Executive Officer

Right. Thank you, Dane. Appreciate the question. Yes, I think for the foreseeable future, we've really tightened the strategic aperture around trilaciclib, just given the sort of pipeline and the molecule potential that it has given the dual benefits of both bioprotection and antitumor efficacy on an array of different tumor types and chemo regimen. So from a capital allocation strategy, that's really where we're highly focused on making sure that we both have a successful launch here in the initial indication along with -- obviously getting a new development plan, all of those studies initiated in the first half of this year. For the foreseeable future, it really is try to focus obviously, we do have rintodestrant, we'll get the readout next quarter on that, but the primary focus for us is really around trialing here for the foreseeable future.

Dane Leone -- Raymond James -- Analyst

Great. Thank you.

Operator

Our next question coming from the line of Anupam Rama with JPMorgan. Your line is open.

Tessa Romero -- JPMorgan -- Analyst

Hey, guys. This is Tess on the call today for Anupam. Thanks for taking our question. Just a quick one on the pipeline, actually, sort of bridging from a prior question. Thinking about the expansion data that we're going to get in 2Q, I was wondering, Raj or anyone else, can you get a little bit more granular for us, what one looks like from a safety perspective? And then just kind of a logistical one. Is this plan to be like a PR or a medical meeting presentation? How are you thinking about that? Thanks so much.

Raj Malik -- Chief Medical Officer

Yes. Tessa. So yes, from a safety perspective, continued good safety profile, we were very -- quite favorable in terms of GI tolerability, and that's what we want to continue to see. Obviously, no bradycardia, no ocular toxicities, which have been issues with some of the other agents as well as cytopenias. So, I think those are the safety signals we would be looking for, and we would expect to present the data at a medical meeting.

Tessa Romero -- JPMorgan -- Analyst

Okay. Great. Thanks for taking our question.

Jack Bailey -- Chief Executive Officer

Sure.

Operator

And our next question coming from the line of Tom Shrader with BTIG. Your line is now open.

Carey Polman -- BTIG -- Analyst

This is Carey Polman for Tom. Thanks for taking our question. For your first-line trial, can you tell us why you chose bladder cancer given sedans and prodima vedotin is going to be in bladder cancer soon. Whereas the frontline in non-small cell lung cancer is more static? And a follow-up on that. Do you plan to do a trial in combination with ADCs because neutropenia is the dose-limiting toxicity for almost all of them?

Raj Malik -- Chief Medical Officer

Yes. Good question. Regarding bladder, our strategic interest in that particular study was to generate data in combination with checkpoint inhibitors. That was certainly the driving force there. I fully understand your comment about Padsev sorry, and that ADC, so we'll have to obviously follow that data in first line when that matures. Yes, in terms of combinations of ADCs, that is an area that we're also exploring for exactly for the reason you mentioned. We actually think there could be two potential ways that we could add to ADCs, not only by improving myelosuppression, but also through this immune enhancing property of COSELA because at the end of the day, the ADC is chemotherapy. And so we've seen additivity to Gemcarbo in triple-negative breast cancer. Yes, I think it makes sense definitely to combine with ADCs, and we're exploring that.

Carey Polman -- BTIG -- Analyst

Got it. And for a triple-negative breast cancer, can you talk about your rationale for not using a checkpoint inhibitor combination because that, to some extent, to some point, is more immunogenic tumor and Atezo is already approved in the frontline setting?

Raj Malik -- Chief Medical Officer

Yes. I think it goes back to our data where we saw activity in both PD-L1 positive and PD-L1 negative, and the checkpoints are only approved in PD-L1 positive, about 40% of the population of metastatic triple-negative breast cancer. So we wanted to enroll all-comers in both PD-L1 positive and PD-L1 negative. If you look at our data, we showed in a relatively small trial, an improvement in survival, which has not been seen with either check white inhibitor. If we're able to reproduce those data, in fact, a combination of trilaciclib with chemo could even potentially be an alternative to a checkpoint inhibitor. So that was our rationale in the first line. In the second line, it is post checkpoint inhibitor, and given the immune mechanism of action. And since trilaciclib is a CDK46 inhibitor, it has a different immune mechanism to checkpoints. We believe there's an opportunity to see activity in the post checkpoint setting, which is clearly an unmet need as well. So that was our rationale behind the design in triple-negative breast cancer. Our second, third line non-small cell lung cancer study is also in a post checkpoint setting.

Carey Polman -- BTIG -- Analyst

Got it. Great. Thanks and congrats on the progress.

Raj Malik -- Chief Medical Officer

Thank you.

Operator

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

David Nierengarten -- Wedbush Securities -- Analyst

Thanks for taking the questions. I had two, if I may. First off, on the bladder cancer study. I'm curious, obviously, it's a bit different than presentation than the triple-negative where you have a fixed cycle of chemo where you're planning the dose COSELA and then dose COSELA in combination with an IO agent afterwards. I was a little curious if there was any way to analyze or break apart the data or potential benefit of COSELA between the -- as you think about the study between the chemo portion and the maintenance therapy with Avelumab? And then quickly on the cash guidance into 2023, is that incorporating OpEx only or presumed revenues? Thanks.

Raj Malik -- Chief Medical Officer

Yes, David. So in terms of -- we would -- that's exactly what we will do. What we're interested in is to look at so for example, patients get up to six cycles of GEM platinum in this regimen. And then if they have not progressed, they go on to receive a Avelumab. So one of the things we'd be interested in looking at given our data with Gemcarbo in triple-negative breast cancer is do more patients actually make it through maintent survival andance of Avelumab? We will be looking at that. And then, of course, we'll be looking a PFS across the entirety of the study, but also from the initiation of maintenance so that we can have a evaluated versus the Javelin in data because, obviously, that trial only -- that trial started from the maintenance portion because only patients who made it on to avelumab were included in that trial. Yes, we'll be looking at the trial overall and breaking it apart into those two components.

Jennifer Moses -- Chief Financial Officer

David, it's Jen. On the runway, when we're looking at -- we actually have a number of ways to get into 2023, and I'm being kind of cautious saying into 2023 and now giving further guidance on it. If you look at the cash balance have after the ATM, you look at the ability to draw down debt, even if we just look at the $30 million, that's available right now. Also, we will -- we are expecting some milestone payments from our partners, not as large as we saw obviously, in 2020, but to add to that runway. And then we would be anticipating revenue. We ran it with a range of revenues. And so we feel very comfortable giving guidance into 2023.

David Nierengarten -- Wedbush Securities -- Analyst

Okay. Got it. Thank you.

Operator

That's all the time we have for questions today. I would now like to turn the call back over to Jack Bailey for closing remarks.

Jack Bailey -- Chief Executive Officer

Thank you, operator. So in summary, 2020 was a strong year of progress for the company. We look forward to keeping you all updated as we continue to progress in 2021. We are excited to bring COSELA to patients with extensive stage small cell lung cancer and look forward to keeping you updated as we move forward. To everyone listening, thank you for joining us today, and please stay well.

Operator

[Operator Closing Remarks]

Duration: 52 minutes

Call participants:

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

Jack Bailey -- Chief Executive Officer

Raj Malik -- Chief Medical Officer

Soma Gupta -- Chief Commercial Officer

Jennifer Moses -- Chief Financial Officer

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

Chad Messer -- Needham -- Analyst

Phil Nadeau -- Cowen -- Analyst

Tony Butler -- ROTH Capital. -- Analyst

Dane Leone -- Raymond James -- Analyst

Tessa Romero -- JPMorgan -- Analyst

Carey Polman -- BTIG -- Analyst

David Nierengarten -- Wedbush Securities -- Analyst

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