Q4 2020 G1 Therapeutics Inc Earnings Call

Ladies and gentlemen, and thank you for standing by and welcome to the G. One therapeutic sport quarter, 'twenty and 'twenty financial results Conference call. At this time, all participants are in listen only mode.

Operator: Ladies and gentlemen, thank you for standing by, and welcome to G1 Therapeutics' 4th Quarter 2020 Financial Results Conference Call. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during this session, you will need to press the star-then-the-1 key on your touch-tone telephone. Please be advised that today's conference may be recorded. If you require operating assistance, please press star-then-0. I would now like to hand the conference over to your speaker host today, Will Roberts, Head of Investor Relations at G1 Therapeutics. Please go ahead.

After the speaker's presentation, there will be a question and answer session to ask a question. During this session you will need to press. The Star then the one key on your touched on telephone. Please be advised that today's conference maybe recorded.

All participants. Please press Star then zero I would now like to hand, the conference Oh, but your speaker host today, well Robert <unk> head of Investor Relations at G. Once Youre predicts. Please go ahead.

Thank you Lydia.

William C. Roberts: Thank you, Livia.

Good afternoon, everybody and welcome to the G. One conference call to discuss our fourth quarter and full year, 'twenty and 'twenty financial results and business update.

William C. Roberts: 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 the 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 Cocella, 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 topatechin-containing regimen for extensive stage small cell lung cancer, or

The press release on these financial results was issued after market close this afternoon and can be found and our new section of our corporate website human therapeutics Dot com.

On this afternoon's call the team will provide an overview.

Of the fourth quarter and full year 'twenty and 'twenty.

Including an update on our launch progress with Casella, which was approved by the U S food and drug administration on February 12, 2021 to decrease the incidence of chemotherapy induced myeloid suppression and adult patients.

When administered prior to our platinum and Toby side containing regimen or towboat, teak and containing regimen for extensive stage small cell lung cancer or E. S. S. G L Sims.

William C. Roberts: 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 Security 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.

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 $19 95.

Such statements represent managements 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 'twenty four 2021.

William C. Roberts: 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.

Joining me on the call today are Jack Bailey, our Chief Executive Officer, Raj Malik 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.

John E. Bailey: 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 a call with you to announce the FDA approval of Cocella, 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 disease.

Thanks good.

Good afternoon, everyone and thank you for joining us on the call today, and we hope that you and your families are well.

Today's headlines and say Gee, one is a very different company than it was a year ago or even last quarter.

And the peak days ago, we were on a call with you to announce yet.

Approval of Costello.

First and only FDA approved therapy, and it's administered proactively to deliver multi lineage and Michael protective benefits to patients with extensive stage small cell lung cancer.

The higher G. One team is energized to be making this important therapy available to cancer patients.

John E. Bailey: 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 range of chemotherapy. We are initiating and conducting clinical trials evaluating Costella across an array of cancers in chemotherapy regimens.

But of equal importance is our rapidly evolving clinical pipeline and Pat.

And would you be designed to help address unmet needs of people with a variety of different cancers, who require a range of chemotherapy.

We are initiating and conducting clinical trials evaluating cross sell across an array of cancers and chemotherapy regimens.

Within the first half of 2021, we expect to have two registrational trials underway, one and colorectal cancer, and which we began dosing patients last month, and another and metastatic triple negative breast cancer, which will initiate in the first half of this year.

John E. Bailey: Within the first half of 2021, we expect to have two registrational trials underway, one in colorectal cancer, for which we began dosing patients last month, and another in metastatic triple negative breast cancer, which we'll initiate in the first half of this year. We will also have three phase two studies underway. These include our I-SPI2 neoadjuvant breast cancer trial, which was initiated last year. And, as we announced in January at the J.P. Morgan Conference, we expect to initiate phase two trials in both non-small cell lung cancer and bladder cancer in the first half of 2021, with each study having anti-tumor efficacy as the primary end.

We will also have three phase III studies underway. These.

These include our I spy, two neo adjuvant breast cancer trial, which was initiated last year and.

As we announced in January at the Jpmorgan Conference, we expect to initiate a phase III trial, and both non small cell lung cancer and.

Bladder cancer in the first half of 2021 with each study you have and anti tumor efficacy as the primary endpoint.

Regarding the bladder cancer trial, we announced and important supply agreement with Merck, <unk>, Darmstadt, Germany, and Pfizer and our press release, this afternoon, which Raj will describe in more detail.

John E. Bailey: 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 the sole purpose of making a difference in the lives of people living with cancer. The launch of Costella is the first step. We believe that CoSellit will be an important therapy in the arsenal for improving the lives of patients with a variety of cancer diagnoses 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.

G. One was founded with the sole purpose of making a difference and the lives of people living with cancer.

The launch of cross sell out is the first step.

We believe that <unk> will be and important therapy and the arsenal for improving the lives of patients with a variety of cancer diagnosis as we work towards the goal of developing it as a tumor agnostic solution for patients with cancer and.

And it also represents an excellent opportunity to bring strong value to our shareholders.

Holders.

This is a transitional call for us given that we're only a few days past turning the corner to becoming a commercial organization and just a few days past our last call with you all on the commercial launch readiness.

John E. Bailey: This is a transitional call for us given that we are only a few days past turning the corner to becoming a commercial organization and just a few days past our last call with you all on 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 Cocella, including a reminder of its mechanism of action, which we believe will be broadly applicable.

While Jim will cover our financial results for the fourth quarter and full year 2020 towards the back end of the call. The rest of the call will largely be forward looking and I will ask Raj to cover our clinical focus with casella, including a reminder of its mechanism of action, which we believe will be broadly applicable.

So Mark will then briefly provide an update on some of our launch efforts over the past eight days <unk>.

John E. Bailey: 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 Cosella in the clinic.

Alluding the ongoing launch meeting being held this week.

And then I'll be back for some concluding comments I'll now turn the call over to Raj for an update on hotel and the corner Ross.

Rajesh K. Malik: Thanks, Jack. And good afternoon, everyone, whoever's on the call with us. This is a very exciting time at G1 as we are in the process of launching Cocella 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 Cocella. So I want to take some time this afternoon to walk you through it, as it will help to clarify the deliberate approach that we are taking to determining the cancers to pursue in the clinic.

Thanks, Jack and good afternoon, everyone.

And whoever is on the call with US. This is a very exciting time at G. One as we are and the process of launching a seller for patients with extensive stage small cell lung cancer.

At the same time developing it and the clinic for a variety of other solid tumors.

Over the past few weeks there has been considerable interest and a single mechanism potential dual benefit of casella and so I want to take some time. This afternoon to walk you through it and how does it will help to clarify the educated and approach that we're taking to determining the cancers to pursue and the clothing.

<unk> is administered as a 30 minute intravenous infusion completed within four hours prior to the startup chemotherapy.

Rajesh K. Malik: Cocella is administered as a 30-minute intravenous infusion completed within 4 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 these cells through the cell cycle. In cancers like small cell lung cancer, chemotherapy is highly myelosuppressive and is 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.

It has a single mechanism of transient G. One cell cycle arrest due to transient CDK <unk> inhibition and susceptible host cells, which temporarily blocks progression of these cells through the sales cycle.

And cash flows like small cell lung cancer chemotherapy is highly myeloid suppressor and given multiple days and 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 hsbc's alike.

Costello transiently arrest, the Hsbc's and the G. One phase of the cell cycle.

Rajesh K. Malik: Cocella transiently arrests the HSPCs in the G1 phase of the cell cycle, thereby protecting and preserving myeloid cell lineages, like neutrophils and erythrocytes, and lymphoid cell lineages, like T and B lymphocytes, from the myelosuppressive damage caused by chemotherapy. The half-life of Cocella is relatively short, approximately 14 hours, and as a result, the This myeloprotection 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 Cosella by the FDA to decrease the incidence of chemo-induced myelosuppression in patients with extensive-stage small-cell lung cancer. We are also exploring...

Thereby protecting and preserving myeloid cell lineages like neutrophils and the rest of our sites and limb.

<unk> cell lineages like T and B lymphocytes from the mildest impressive damage caused by chemotherapy.

The hospitalized for casella as relatively short approximately 14 hours and as a result, the hsbc's quickly recover and start to produce mature blood cells.

This model and protection benefit was conclusively demonstrated and our three double blind placebo controlled trials and extensive stage small cell lung cancer, which led to the approval of <unk> by the FDA to decrease the incidence of chemo induced model suppression and patients with extensive stage small cell.

Lung cancer.

We are also exploring whether casella 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 antitumor immune response by increased.

Rajesh K. Malik: Through a combination of factors. One, through the protection of the immune system, allowing it to function after chemotherapy. And two, by enhancing the 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 responses, and by increasing clonal expansion of these. In addition, Cocella may increase the patient's ability to receive a longer duration of chemotherapy, which can also contribute to Cocella appears to activate a T-cell-mediated immune response with clinical evidence of improved anti-tumor efficacy when the tumor is immune responsive.

The ratio of effector CDA positive T cells, and immuno suppressive T regulatory cells.

Which is important to immune priming baidu.

By directly activating CDA positive T cells to improve T cell mediated response.

And by increasing clonal expansion of T cells.

In addition, casella and increase the patient's ability to receive a longer duration of chemotherapy and as such can also contribute to improving antitumor efficacy.

Casella appears to activate a T cell mediated immune response with clinical evidence of improved antitumor efficacy when the tumor is immune responses.

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 and the last set oncology.

Rajesh K. Malik: This benefit was shown in the clinical data from the triple negative breast cancer phase two 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 2 trial of Cosella in combination with gemcitabine and carboplatinum, the 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.

This randomized open label Phase II trial of a seller and combination with Gemcitabine and Carboplatin and 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.

<unk> cancer.

And there's three arm trial, all three groups received and chemotherapy regimen of Gemcitabine and Carboplatin.

Rajesh K. Malik: In this three-arm trial, all three groups received a chemotherapy regimen of gemcitabine and carboplatin. Patients were randomized to receive GEMCARBO only in Group 1, or GEMCARBO plus COSELLA administered on the day of chemotherapy in Group 2. Or GEMCARBO plus COSELLA administered the day prior to and the day of chemotherapy, group 3. The survival results were pretty remarkable, and compared to GEMCARBO alone, overall survival was significantly improved in both Cosella arms. And importantly, patients with both PD-L1 positive and PD-L1 negative tumors treated with Cocella prior to their GEMCARBO demonstrated improvement in OS compared to patients receiving GemCarbo alone, with the PD-L1-positive subset achieving statistically significant improvement.

Patients are randomized to receive either gem carbo, only and group one gem carbo, plus casella administered on the day of chemotherapy group too.

Carbo, plus casella administered the day prior to and the day of chemotherapy group three.

The survival results were pretty remarkable and compared to gem carbo alone overall survival was significantly improved and both casella arms.

And importantly patients with both PD lone positive and PDL, one negative tumors treated with a seller price.

<unk> two is our gem carbo.

Demonstrated improvement and O S compared to patients receiving gem carbo alone with the PD lone positive subset achieving statistically significant improvement.

We will initiate a registrational trial and patients with metastatic triple negative breast cancer and the first half of this year.

Rajesh K. Malik: We will initiate a registrational trial in patients with metastatic triple negative breast cancer in the first half of this year to evaluate Cocella in combination with a chemotherapy regimen of Gemcarbo in two separate doses, as first-line treatment in 170 patients who are checkpoint inhibitor treatment nave and as second-line treatment in 80 patients whose disease has progressed following prior checkpoint inhibitor therapy. Both cohorts are adequately and independently powered, and we will provide more information on trial design when we announce the initiation of this trial.

And to evaluate casella and combination with chemotherapy regimen of gem carbo in two separate cohorts.

As first line treatment and 170 patients who are checked and checkpoint inhibitor treatment naive and a second line treatment and 80 patients whose disease has progressed following prior checkpoint inhibitors.

Both cohorts are adequately and independently power and we will provide more information on trial design, when we announced initiation of this trial.

And other thing we have learned is that the best place to see the bylaw protection benefit I discussed earlier is and chemotherapeutic regimens that require administration and I'll chemotherapy on multiple days and our ROE.

Rajesh K. Malik: Another thing we have learned is that the best place to see the viral protection 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 Folfoxiri and Bevacizumab, the most efficacious chemotherapeutic regimen in colorectal cancer but also the most myelosuppressive. Patients receiving Folfax Siri are administered Arenotecan, Oxaliplatin, and Bevacizumab on day one, and then a continuous infusion of 5-FU over 48 hours starting on day one.

That leads us to our approximately 300 patient registrational trial in colorectal cancer, which began enrolling patients in January.

And this trial patients received full Fox theory, and Bevacizumab and most efficacious chemo regimen and colorectal cancer, but also the most modest suppressor.

Patients receiving full Fox here are administered arena T can of valley platinum and Bevacizumab on day, one and then a continuous infusion of <unk> five S. You over 48 hours starting on day one.

After 12, two week induction cycles with all chemotherapy agents.

Rajesh K. Malik: After 12 two-week induction cycles with all chemotherapy, 5-FU and velocizumab are continued in maintenance until disease progression. Patients will receive Cosella or placebo prior to chemotherapy on day one and again on day two during the 5FU infusion every cycle during induction and maintenance. The primary endpoints for myeloprotection include duration of severe neutropenia in cycle one and occurrence of severe neutropenia.

<unk> and Bevacizumab or continued and maintenance until disease progression.

Patients will receive casella or placebo prior to chemotherapy on day, one and again on day two during the five a few infusion with every cycle during induction and maintenance.

The primary endpoints for motto protection include duration of severe neutropenia in cycle, one and occurrence SUV and neutropenia.

And the secondary endpoints include progression free survival, and overall survival and patient reported outcomes.

Rajesh K. Malik: And the secondary endpoints include progression-free survival and overall survival and patient-reported outcomes. Eighty percent of the alpha is reserved for the myeloprotection endpoints, but we have reserved twenty percent of the alpha for the anti-tumor efficacy endpoints. We expect data readout in the first half of 2020.

80% of the Alpha is reserved for the model of protection and points, but we have reserved 20% off the alpha or the antitumor efficacy endpoints and we expect the data readout and the first half of 'twenty and 'twenty three.

In addition to those Registrational trials, we announced in January that we expect to initiate two additional phase II trials of casella, and non immunogenic tumors and the first half of this year.

Rajesh K. Malik: In addition to those registrational trials, we announced in January that we expect to initiate two additional phase two trials of Casella in known immunogenic tumors in the first half of this year. The first is a randomized open-label trial in first-line locally advanced metastatic bladder cancer, also called locally advanced or metastatic urothelial carcinoma. Cosella 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 Cocella in combination with a checkpoint inhibitor, Velumab, until disease progression.

The first is a randomized open label trial and first line locally advanced or metastatic bladder cancer.

And so called locally advanced or metastatic <unk> carcinoma.

Casella and will be administered prior to Gemcitabine platinum chemotherapy, which has a similar regimen to the one we used and the triple negative breast cancer trial.

Solid by maintenance therapy of Casella, and combination with the checkpoint inhibitor a value mark until disease progression.

So that and we were happy to announce this afternoon and our financial results and business update press release that we have entered into a clinical trial collaboration with Merck <unk> Darmstadt, Germany, and Pfizer, whereby the alliance will contribute to clinical supply of value map to this first line metastatic.

Rajesh K. Malik: 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 KGA, Darmstadt, Germany, and Pfizer, whereby the alliance will contribute clinical supply of Evalumab to this first-line metastatic urothelial carcinoma trial. The primary efficacy measure of the trial is anti-tumor efficacy, and we expect to The second is a randomized double-blind phase 2 trial in second-line and third-line patients with non-small cell lung cancer who have progressed following checkpoint. Patients will receive Cosella or placebo prior to each administration of dose attacks.

Got it.

Carcinoma trial.

The primary efficacy measure of the trial as antitumor efficacy and we expect to have initial data in late 2022.

The second is a randomized double blind phase II trial, and second line and third line patients with non small cell lung cancer, who have progressed following checkpoint inhibitors PE.

Patients will receive casella or placebo prior to each administration of Docetaxel.

Primary efficacy measure after trial is again antitumor efficacy and we expect interim data and the first half of 'twenty and 'twenty three.

Rajesh K. Malik: The primary efficacy measure of the trial is, again, anti-tumor 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 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.

Rajesh K. Malik: We will keep you updated as the investigator-sponsored studies get up and running. I want to touch briefly on our oral CERD rintrodestrant as well. The mature monotherapy data from our Phase 1b 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 search. We also saw robust target engagement and a clinical benefit rate, or CBR, of 30 percent, in the ballpark of what is seen with other oral search techniques.

I want to touch briefly on our oral surgery rental desk strength as well.

Mature and monotherapy data from our phase one b trial and are heavily pretreated population of ER positive <unk> negative patients.

<unk> at the 'twenty and 'twenty, San Antonio breast cancer Symposium confirming the results of the preliminary analysis we.

We reported good safety and Tolerability, which is important for an oral sir.

We also saw robust target engagement and a clinical benefit rate, our CBR up 30% and.

And the ballpark of what is seen with other oral surgeons.

We advanced and 800 milligram dose of rental desk trial into a phase II combination trial with all the sites and last year and 40 patients who are somewhat less heavily pretreated and those in the phase one b.

Rajesh K. Malik: We advanced an 800 milligram dose of rintodestranth into a phase two combination trial with Albicyclib last year in 40 patients who are somewhat less heavily pretreated than those in phase one. 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 Costello launch. Okay, Soma?

Enrollment was completed in October 2020, and we expect to announce initial safety and efficacy results and the second quarter of 2021.

With that I'll turn the call over to sell about our update on the first couple of weeks of the Casella launch Soma.

Thanks, Raj and good afternoon, everyone. Thanks for joining us on the call.

Priyanka Arun Grover: 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 Cocella, 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, but 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 for Approval.

These are exciting and very busy times and we are commercially launching kosawa completing the training of our sales force and generating brought 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 and today's prepared comments will be fewer and focus on and why.

We've accomplished and the last week or so.

I will first briefly comment on our baseline awareness preapproval.

<unk> conducted a series of surveys over the past several months to a thoughtful awareness and interest and usage and we will continue to do so going forward.

Priyanka Arun Grover: We will continue to do so going forward. Based on our final pre-approval survey, awareness trends have continued to go our way. In a sample of 75 positions 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 Cocella 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.

And our final pre approval survey awareness trends have continued to grow our way.

Sample of 75 physicians with a 70% community 30% academic split.

Aided awareness is at 50% what is a significant jump from 30% in November and is in line with what we would expect from similar benchmarks and the states.

Also the percentage of oncologists, who are engaging and prophylaxis for some portion of their patients well, we think of as providers, who will be most receptive to the cross sell of proactive protection message has increased from 66% in June of last year to 77% today lifestyle, driven at least and part.

And the sensitivity and the COVID-19 pandemic environment.

We were also glad to see the latest metrics for our mindless of price and disease State education campaign indicate that 30% of our tier one to three targets have engaged with the content and many of you know this is well above the expected benchmark of 8% to 10%, suggesting that this is a topic providers have interest and learning more about.

Priyanka Arun Grover: We were also glad to see the latest metrics for our Myeloid Suppression Disease State Education Campaign indicate that 30% of our Tier 1-3 targets have engaged with the content. As many of you know, this is well above the expected benchmark of 8-10%, suggesting that this is a topic providers are interested in learning more about. Interestingly, our survey data also indicate a steady increase in unaided mentions of non-neutropenia-related concerns of chemo-induced mild suppression, like severe anemia and dose reductions or delays, more than a doubling from prior to the campaign, and even higher if you ask nurses. All in all, a good foundation on which to launch Crisella.

Interestingly our survey data also indicate a steady increase and unaided mentioned non neutropenia related concerns of chemo and day smiles suppression like severe anemia, and dose reductions or delayed more than a doubling from prior to the campaign and even higher if you ask nurses.

And all a good foundation on which to launch that's all.

And I can say walnut close how approval, which was February 12.

And the field force, including our GPO account managers clinical nurse educators, our national accounts team managed markets and the Boehringer Ingelheim and sales reps have begun their outreach to set up appointments with our tier one telco providers.

Priyanka Arun Grover: As of day one of CLOSELA approval, which was February 12th, the field force, including our GPO account managers, clinical nurse educators, our national accounts team, managed markets, and the Beringer Ingelheim sales reps, have begun their outreach to set up appointments with our Tier 1 target providers. Detailing and presentations will start immediately after our reps are certified as of the end of this week. I'm happy to confirm the drug is planned to be in the channel around this time also, as we are on target for March 2nd.

Retail and presentations, we will start immediately after our reps are certified as of the end of this week.

And how can you confirm drug is planned to be and channel around this time also as we are on target for March 2nd Alright, and south have and engaging with physicians for months and peer to peer discussions about the multi lineage impacts of miles suppression and have now added the approval of the product to their conversations.

Mark the early anecdotal feedback has been very positive for example, one community and provider told US that this is exactly what we wanted to see and our practices and channel.

Priyanka Arun Grover: Our MS models have been engaging with physicians for months in peer-to-peer discussions about the multilineage impacts of myosuppression 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 they want to see in their practices and to know that giving this drug can save patients from adverse events and hospitalizations.

And now they're giving this drug can save patients from adverse events and hospitalizations.

Activity from payers has included comments like the following from a national plan and medical director Who's Sad I Plod G. One for finding a way to achieve one therapy to address miles and suppression as opposed to multiple treatments where he is now.

This is just a sampling of the positive feedback we have received thus far.

Since approval our G. P. L account directors indicate several of the large community practices already taking initial steps to get trial looks like well reviewed and added to formulary.

Priyanka Arun Grover: Similar positivity from payers 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 mild depression as opposed to the multiple treatments we use now.

Launch sequence has been very intentional and the activities for days, one through seven and approval support the goals of first getting and you see and submission and to get closer look quickly added to the guidelines.

Priyanka Arun Grover: This is just a sampling of the positive feedback we have received thus far. Also, since approval, our GPL account directors indicate that several of the large community practices are already taking initial steps to get trial cycles reviewed and added to formulary. Our launch sequence has been very intentional, and the activities for days 1 through 7 of approval support the goals of, first, getting our NTCN submission in to get CoSella quickly added to the guidelines, second, completing all pricing compendia submissions to enable reimbursement, ordering, and flow of treatment guidelines into EHRs, and third, getting the sales team certified on the label and on core marketing materials. Regarding MCCN, Rajesh's medical affairs team has already completed our formal MCCN submission.

And completing all pricing comes down to your submission to enable reimbursement ordering and flow treatment guidelines and Ehr's and third getting the sales team certified on the label and on core marketing materials.

Regarding MCC and Raj and his medical affairs team has already completed our formal and Susie and submissions, we hope to see cross sell and added to the guidelines and a few months regarding the pricing comes down to your submission our market access team has submitted to all price incompatible.

And medical Affairs team has some and it's all other clinical compound here as well.

Regarding the sales team Inc.

And their initial training on the label last week today is day two of the four day, Chris that will launch meeting.

Strong emphasis on training and practice workshops is important to clarify that we are giving this launch meeting remotely and virtually with a socially distance that and adherence to COVID-19 mitigation procedures, despite being in a virtual setting. This launch meeting has all the hallmarks of a.

Priyanka Arun Grover: We hope to see Cocella added to the guidelines in a few months. Regarding the pricing compendia submission, our market access team has submitted to all pricing compendia, and the medical affairs team has submitted to all other clinical compendia as well. Regarding the sales team, they completed their initial training on the label last week. Today is day two of the four-day Cocella launch meeting, which has a strong emphasis on training and

Traditional in person and line, including training sessions on various topics such as M. A way package insert and the core interactive sales day, there will be exercised as focused on effectively overcoming objections education panel, featuring HCP is and oncology nurses and inspirational sessions devoted to patient journey and caregivers stories.

In parallel we're also activating a robust branded digital campaign to drive awareness and augments our sales force effort at the end of this program every rep will be fully trained and certified and ready to sell and person where possible and virtual where needed or preferred early next week with product.

Priyanka Arun Grover: It is important to clarify that we are doing this launch meeting remotely and virtually with a socially distanced set and adherence to COVID-19 mitigation procedures. Despite being in a virtual setting, this launch meeting has all the hallmarks of a traditional in-person one, including training sessions on various topics such as the MOA, package insert, and the core interactive sales page. There will be exercises focused on effectively overcoming objections, education panels featuring HCPs and oncology nurses, and inspirational sessions devoted to the patient journey and caregiver stories.

And channel ready to order on March 2nd.

The team has already started to invite our target physicians and nurses and pharmacists tour upcoming national broadcast and some of the most experienced oncologists will educate their peers on the impact of chemo and do small suppression and costar with clinical trial data at the session.

National broadcast is scheduled for March and make that what's and encore on the 26.

Priyanka Arun Grover: In parallel, we are also activating a robust branded digital campaign to drive awareness and augment the Salesforce efforts. At the end of this program, every rep will be fully trained, certified, and ready to sell in person where possible, virtual where needed or preferred, early next week, with product and channel ready to order on March 2nd.

Cash will include a panel presentation and discussion with Doctor and Kim by physician and cheap at city of Hope National Medical Center, that's and Mohammed Muhammad director of thoracic oncology at cone Health Cancer Center, and Dana Herndon thoracic oncology nurse also at Cornhouse, it's probably.

Priyanka Arun Grover: 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 mild suppression and CoSella clinical trial data at this session. The national broadcast is scheduled for March 25th with an encore on the 26th.

Worth reminding folks and about 1500 first line small cell lung cancer patients are treated each month across the country. We expect to follow that would be considered for use and 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, we'll learn.

Well providers first four and a box or a silo and then find an appropriate patient and soon to gain some experience and then move it into their practice more broadly.

Priyanka Arun Grover: The broadcast will include a panel presentation and discussion with Dr. Ed Kim, Vice Physician in Chief at City of Hope National Medical Center, Dr. Mohamed Mohamed, Director of Thoracic Oncology at Cone Health Cancer Center, and Dana Herndon, a Thoracic Oncology nurse also at Cone Health. It's probably worth reminding people that about 1,500 first-line small cell lung cancer patients are treated each month across the country. We expect COSELLA to be considered for youth and newly diagnosed patients versus the pent-up demand we might see for therapeutics.

All of this to say that by beginning of next week, we'll be fully teed up with branded profile and marketing materials to actively promote casella and supporting it skews to oncologists oncology nurses and payers, we expect the entirety of our field force to communicate the advantages that can follow up with materials and hand and products and channel.

Ready to improve the chemotherapy experience with small cell lung cancer patients. That's a very exciting time for both the commercial teams at G. One N V ally and what.

That I will turn the call over to general.

Ken.

Thanks, Soma and good afternoon, everyone.

Mentioned full financial results for the fourth quarter and full year 2020 are available and our press release and 10-K.

Priyanka Arun Grover: We therefore expect this to be a steady climb over the first few months as providers first learn about COSELLA, then find an appropriate patient with whom to gain some experience, and then move it into their practice more broadly. All of this to say that by the beginning of next week, we'll be fully teed up with branded Cocella marketing materials to actively promote Cocella and support its use among oncologists, oncology nurses, and payers.

Today I'd like to focus on a few key points from our disclosures.

License revenue for the fourth quarter of 2020, $16 5 million primarily related to an upfront payment for a license agreement with <unk>, which provides them with development and commercialization rights for <unk> across all indications and greater China.

This payment was recognized following the transfer of the related technology, and Knowhow, which occurred during the period and.

In addition, we recognized revenue for existing inventory transfer is related to our license agreements with <unk> and <unk> as well as revenue for Reimbursable clinical trial costs due from each of our App.

Priyanka Arun Grover: We expect the entirety of our field force to communicate the advantages of Cocella with materials in hand and products in the channel ready to improve the chemotherapy experience of small cell lung cancer patients. It's a very exciting time for the commercial teams at G1 and NBI. And with that, I'll turn the call over to Jen Moses.

License revenue for the full year 2020 was $45 3 million.

G ones research and development expenses for the fourth quarter of 2020 were $16 4 million down from $24 5 million for the fourth quarter of 2019.

Jen Moses: Thanks, Thoma, 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 10K. Today I'd like to focus on a few key points from our disclosure. License revenue for the fourth quarter of 2020 was $16.5 million, primarily related to an upfront payment for our license agreement with Sincere, which provides them with development and commercialization rights for trial cyclists across all indications in Greater China.

The decrease was primarily due to a decrease and clinical program costs external costs related to discovery and preclinical development and costs for manufacturing pharmaceutical active ingredient.

We expect our clinical program costs to increase as we initiate our two new phase III trial, and a registrational trial and can be seen T. N. B C. Later this year.

Our general and administrative expenses for the fourth quarter of 2020 were $24 3 million double the $12 1 million and the fourth quarter of 2019.

And that would be expected the increase was largely due to an increase in compensation due to additional head count and increases and pre commercialization activities and medical affairs costs related to preparing the company and the market for the launch of Casella.

Jen Moses: This payment was recognized following the transfer of the related technology and know-how which occurred during the period. In addition, we recognize revenue for existing inventory transfers related to our license agreements with Genore and eQRX for Lerocyclib, 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 were $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 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 14th and February 9th of 'twenty and 'twenty. One we sold 3 million and 513027 shares of common stock pursuant to our 2018 sales agreement for aftermarket offerings with Cowen and company, resulting in $86 4 million and that protein.

This activity utilized all remaining capacity under the sales agreement. So this ATM offering is now closed and all.

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 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.

Thank you Jim Solman Rush before we close the call I want to underscore and without the participation of people living with extensive stage small cell lung cancer and <unk>.

Jen Moses: We expect our clinical program costs to increase as we initiate our two new Phase 2 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 and medical affairs costs related to preparing the company and the market for the launch of Cocella.

And please doctors nurses and caregivers, we would not be making cross sell are available Tonight we.

We are grateful for their support and humbled to be part of your community. We will work hard everyday to improve the chemotherapeutic and experience of people living with extensive stage small cell lung cancer.

Now as I mentioned at the start we are very different company than we were a year ago or even a quarter ago.

Our first product <unk> was approved and will soon be available for patients living with extensive stage small cell lung cancer, we are developing a broad and growing clinical pipeline of intelligently designed trials across an array.

Cancers, and chemotherapy therapeutic regimens with boat model protection and antitumor efficacy endpoints.

Jen Moses: We ended the year with cash and cash equivalents of $207 million, slightly above our year-end cash guidance of $200 to $205 million. Subsequent to the reporting period, between January 14th and February 9th of 2021, we sold 3,513,027 shares of common stock pursuant to our 2018 sales agreement for at-the-market offerings with Callan & 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.

To deliver on our tumor agnostic vision for Casella.

With the additional $86 million from our aftermarket 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 and the near term.

And we have a team of experienced professionals throughout Q1 solely dedicated to bringing new therapies to cancer patients who need them.

This all gives me the confidence as we've turned the corner to commercialization while at the same time advancing the development of cross sell and a tumor agnostic map.

As we proceed with commercialized and cross sell we will be open and 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, both leading and lagging indicators of interest and uptake along.

Jen Moses: 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 Cosella 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.

And with our revenue results every quarter and starting with the results of the current quarter.

With that I'll close the call and turn it over to <unk>.

Operator would you please remind our listeners how to ask a question.

Yes.

Thank you ladies and gentlemen, as your line is to ask a question you will need to price the spa agenda. One key on your Touchtone telephone to withdraw your question press the pound key.

John E. Bailey: Thank you, Jen, Salman, and Raj. Before we close the call, I want to emphasize 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 Cocella available. We are grateful for their support and humbled to be part of your community. We will work hard every day to improve the chemotherapeutic experience of people living with advanced stage small cell lung disease.

And Bob will be compile the Q&A roster.

Our first question coming from the line of Ed White with H C. Wainwright. Your line is now open.

Alright, thanks for taking my questions.

And so maybe just start off with a couple of questions for Jim.

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.

John E. Bailey: 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, Cocella, is approved and will soon be available for patients living with extensive stage 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 anti-tumor efficacy input to deliver on our tumor-agnostic vision for Cocella.

Guidance for cash to last through 2023.

Yeah.

Thanks, Ed.

Eight the full $80 million is not included and because we have the ability to access the $30 million and including that and the guidance into 2023 to access the additional portion of the Hercules facility its revenue base for $30 million of it and the additional $20 million is that their discretion. So we <unk>.

To meet additional milestones later in this year.

Great. Thank you.

And then a question for Soma just one thing you had mentioned was that.

John E. Bailey: With the additional $86 million from our at-the-market offering, 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.

Non aided.

Patients had concerns over and myeloid suppression and I'm just wondering if do you have plans for any DTC.

Advertising.

Yes sure.

Sure happy to take that and so what we actually think because small cell is is and urgently presenting disease.

Broad based DTC for small style, you know probably doesn't make sense, but what we do you think is critical is working with advocacy. So we've actually been doing quite a bit with let's go to segmentation and longevity.

John E. Bailey: This all gives me confidence as we turn the corner to commercialization while at the same time advancing the development of Cocella in a tumor-agnostic way. As we proceed with commercializing Coacella, we will be open and 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?

We.

And what will happen is once they get a diagnosis and.

They will very quickly.

The major advocacy organizations to get their information. So we actually think that that's the best way to get that in their hands versus big DTC.

You know, which obviously it 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. So we're being very targeted about it we are doing some digital and digital computer.

Operator: Thank you, ladies and gentlemen. As a reminder to ask a question, you will need to press the star, then the one key on your touchtone telephone. To withdraw your question, press the pound key. Please stand by while we compile the Q&A roster. Now, the first question comes from the line of Ed White with ICSI Wainwright. Your line is open.

Our 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 treatment.

Great. Thank you.

And then my last question is for Raj just.

Edward Patrick White: Alright, thanks for taking my questions. So maybe just start off with a couple of questions for Jen.

You gave great guidance over the timing of data force some of the trials and I'm just wondering.

Edward Patrick White: 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.

If you can give us some thoughts on timing for data for their triple negative breast cancer.

Trial and also the bladder cancer. Thank you.

Jen Moses: 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, it's revenue-based for $30 million of it, and the additional $20 million is at their discretion. So, we expect to meet additional milestones later this year.

Yeah, Hi, Ed, Yes for the TWC and it'll be the second half of 'twenty and 'twenty three.

And for the bladder cancer, we expect initial data.

Later next year towards the end of 2022.

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

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

Great. Thanks for taking my questions.

And maybe to start.

E as you're out there.

Edward Patrick White: Great, thank you. And then a question for Soma. Just one thing you had mentioned was that non-aided patients had concerns over myelosuppression.

And preparing to bring this drug to patients.

Is there a profile that you think doctors have for for the initial patients they might try.

Edward Patrick White: I'm just wondering if you have any plans for any DTC advertising.

Priyanka Arun Grover: Yes, sure. I'm sure happy to take that.

To get this on maybe by risk factor or line of treatment or something like that or.

Priyanka Arun Grover: So what we actually think, because small cell is an urgently presenting disease, so broad-based ECC for small cell probably doesn't make sense, but what we do think is critical is working with advocacy. So we've actually been doing quite a bit with GoToFoundation 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.

Or do you think kind of first available as of March 2nd.

Yeah. Thanks, Jeff for that question I really think because of the profile and the benefits that <unk> brings really any patient who's got extensive stage small cell lung cancer is really the target and we talk about first time every time they get put on chemotherapy. So.

Given that every patient and.

And that first line regimen that we studied and have and our label that those benefits both in terms of.

The reductions and.

Level, but also feeling better and we believe that ultimately it's not a question of.

Parsing out patients, but rather it's really every patient first time every time, whose scott.

Priyanka Arun Grover: So 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. So 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 treatment.

Census stage small cell lung cancer.

Yeah, No I think Kevin.

So as like that makes sense.

And perhaps just one on the rental data.

And that's coming up can you help us benchmark what good efficacy based on sort of the competitive landscape would look like and combination with <unk>.

Edward Patrick White: Great. Thank you. And then my last question is for Raj. You gave great guidance on the timing of data for some of the trials. I'm just wondering if you could give us some thoughts on timing of data for the triple negative breast cancer trial and also bladder cancer. Thank you.

Yeah, Hey, Chad Raj here, Yeah. So in this 40 patient dataset, where winter was combined with Paolo the patient population was less heavily pretreated compared to our monotherapy data set.

And closer to the population that was enrolled and the Paloma three trial.

And that trial, the clinical benefit rate at six months was 64%.

Rajesh K. Malik: Yeah, hi Ed. Yeah, for the TMBC, it'll be the second half of 2023. And for bladder cancer, we expect initial data later next year, towards the end of 2023.

So what we will be looking for interest continued good safety and Tolerability profile, we saw as a monotherapy.

And a CBR rate and that 60% to 65% range.

Edward Patrick White: Okay, great. Thank you very much for taking my questions.

Alright, great. Thank you very helpful.

Welcome.

Next question coming from the line of Bill and then do with Cowen Your line is open.

Chad Messer: Our next question comes from the line of Chad Messer with Neham. Your line is open.

Yeah.

Priyanka Arun Grover: Great. Thanks for taking my questions. 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 do you think first available as of March 2nd?

Good afternoon, and thanks for taking my questions a couple of and the commercial side.

You mentioned and companion debt submissions have been made can you remind us are some competitor and more important and others, which are the ones that that are particularly influential.

Someone can you handle that please.

Yeah sure. So obviously, you know companions, a pretty broad category of things I think and see how it is sort of any companion and of itself. So that is clearly the gold standard there are additional ones that are in the mix that drive pathways for kind of was it a larger G. P O.

Priyanka Arun Grover: Yeah, thanks, Chad, for that question. I really think because of the profile and the benefits that Cosella brings, any patient who's got extensive stage small cell lung cancer is really the target. And we talk about first time every time they get put on chemotherapy. So given that every patient in that first line regimen that we studied and have on our label gets 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 first time every time who's got extensive stage small cell lung cancer.

Type type environments.

And those are those are ones that we have spent as shown on the clinical side and then on the payer on a kind of more payer access side things like micro med acts lexi drugs things like that and also submitted to them. So that they can sort of flowing through the EHR systems. So there's multiple different ones and where we're actively pursuing each.

Chad Messer: Um, yeah, no, I think given all the cell is like that makes sense. Um, perhaps just one on the Rinto data that's coming up. Can you help us benchmark what good efficacy would look like based on, you know, sort of the competitive landscape with Palbo?

Each one but as you see on is the <unk>.

Go to our guide for them for <unk> and you know Wow.

It is very influential and on the other pathways and I guess is the best way to put it.

Rajesh K. Malik: Who am I?

Rajesh K. Malik: Yeah, hey Chad, Raj here. Yeah, so in this 40 patient data set where RINTA was combined with PALBO, the patient population was less heavily pretreated compared to our monotherapy data set and closer to the population that was enrolled in the PLOMA-3 trial. And in that trial, the clinical benefit rate at six months was 64 percent. So what we will be looking for is continued good safety and tolerability. The profile we saw as monotherapy and the CBR rate in that

Got it okay. That's very helpful and in terms of and C. C and specifically do they host meetings, where they come to determinations or is there a defined.

Protocol that they worked through as they're assessing new drugs or has it got more and more on the fly and just as drugs are available and they tend to consider them.

Yes.

And so the haynesville.

So we submitted.

The applications to both the small cell lung cancer and the hematopoietic growth factor a guideline committees.

Typically what they will do is with new drug approvals, they will meet and whatever they are able to pull the guideline committees together.

Chad Messer: All right, great, thank you. Very helpful. Welcome.

Phil Bendu: Our next question comes from the line of Phil Bendu with Kowan. Your line is open.

And review of the evidence. So that's why we think it would take a few months.

And so they often do that outside of their regularly scheduled meetings, which occur annually.

Phil Bendu: Good afternoon. Thanks for taking my questions. A couple on the commercial side.

Got it and maybe last question from us before the NCC and comes out.

Priyanka Arun Grover: You mentioned compendia for which submissions have been made. Can you remind us, are some compendia more important than others? Which are the ones that are particularly influential?

And so utilization likelihood I guess.

How closely do too.

Physicians and practices adhere to the <unk> guidelines will be.

Phil Bendu: Selma, can you handle that, please?

Priyanka Arun Grover: Yeah, sure. So, obviously, the compendium is a pretty broad category of things. I think NCCI is sort of a compendium of itself, so that is clearly the gold standard. There are additional ones, though, that are in the mix that drive pathways for, you know, kind of within a larger TPO-type environment, and those are ones that we have submitted to on the clinical side.

New medicines prior to the guidelines or is it similar to the CIP recommendation for vaccine, where the NCC and guidelines are a major catalyst for uptake.

Yes, Phil this is Jack thanks for the question.

And we'll get some utilization prior to MCC and but that is an important point or travelers to Soma earlier point is that triggers the original pathway and organizations and enables a lot of times organizations to then did it and the things like Mark said, but you will get some utilization. It's just it's a very.

Phil Bendu: Got it. Okay, that's very helpful. And in terms of NCCN specifically, do they host 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 done more on the fly, just as drugs are available? Yeah. I'm going to improvise.

Very helpful and endorsement.

Oncology space to get them to endorse and as Rob said, we're probably a couple of months, particularly Japan perfect. Thanks for taking my questions and congratulations on the progress. Thank.

Thank you Bill.

Rajesh K. Malik: Yeah.

Rajesh K. Malik: Yeah, hey Phil. Yeah, so we submitted the applications to both the small cell lung cancer and the hematopoietic growth factor guideline committees. Typically, what they will do with new drug approvals is they will meet whenever they're able to pull the guideline committees together and review the evidence. So that's why we think it would take a few months, but they often do that outside of their regularly scheduled meetings, which occur

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

Yes, Hey Raj.

I wanted to just touch on.

The trial and and bladder cancer with the ability to map and and I wanted to understand with the trial actually mimic javelin 100.

And the effectively the first question and and secondly.

The key is due do you actually.

<unk> utilized Costello.

Phil Bendu: Got it. And maybe last question from us: before the NCCN comes out... Is utilization likely? I mean, how closely do 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?

During the because you do have first line platinum chemo before you actually put and Seo on top of with respect to maintenance.

Do you actually put casella onboard.

Just during the chemotherapy phase and then it stops as affiliate and that comes on board.

John E. Bailey: Yeah, Phil, this is Jack. Thanks for the question. We will 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 organizations to then get into things like ORG-SET. But you will get some utilization. It's just a very helpful endorsement, obviously, in the oncology space to get them to endorse it. And, as Rajesh said, it will probably be a couple months from now.

Just want to clarify.

Yes, Hi, Tony.

And Youre absolutely right javelin 100 is the sort of the model and if you will I mean thats the.

And the standard with a value mab maintenance following up to six cycles of platinum therapy.

So our trial is going to include cross sell our.

Administered with the chemotherapy and with the value map maintenance with the control arm being of course, just the chemotherapy alone and a value add and maintenance.

And essentially it's an add on to that standard of care.

Phil Bendu: So we get that. Perfect. Thanks for taking my questions and congratulations on the progress.

That's great and then again, if I may the readout is.

Overall survival.

Tony Butler: Thank you.

Tony Butler: The next question comes from the line of Tony Butler with Watt Capital. Your line is open.

Is that.

Fair or is there a PFS readout.

And what is one and effect would be the primary.

Tony Butler: Yes, hey, Raj, um... I want to just touch on the trial in bladder cancer with the ViliaMap, and I wanted to understand whether the trial would actually mimic... Javelin 100.

Yeah. So we'll provide more details on that Tony when we when we describe.

Describe the trial the diesel and we'll all be antitumor efficacy readouts with the initial readouts being.

Tony Butler: effectively the first question. And secondly, the key is, do you actually

Towards the end of next year, as I mentioned, which will likely be more response rate focused with others to follow.

Tony Butler: We utilize Cosella during the because you do have first-line platinum chemo before you actually put Vivencio on top with respect to maintenance. Do you actually put Cosella on board? Just during the chemotherapy phase, and then it stops as Avilumab comes on board. I just want to clarify, thanks.

Thanks, Ross I appreciate it.

Sure.

Yes.

And our next question coming from the line of day, and Leon <unk> with Raymond James Your line is open.

Hi, Thank you for taking my questions congratulations on the launch and and thank you for providing the details around that.

I just wanted to ask more of a strategic question.

Rajesh K. Malik: Hi Troy, Hi.

Rajesh K. Malik: Yeah, you're actually right, John.

What do you think about the company going into the launch.

Rajesh K. Malik: of the model, if you will. I mean, that's the standard with value-mapped maintenance following up to six cycles of gem platinum therapy. So our trial is going to include Cosella administered with the chemotherapy and with the value-mapped maintenance, with the control arm being, of course, just the chemotherapy alone and a value-added maintenance. So essentially, it's an add-on to that standard of care.

Of trial and <unk>.

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 it.

And externally or bringing it and do you view and G. One therapeutics is focused more on supportive care for oncology at this point and that's where the synergy it would be with the channel you're building or.

Or would you also.

Tony Butler: That's great. And then, again, if I may, the readout is:

And look at.

More traditional assets that would be directly targeting the tumors as well how are you thinking about the company's strategy is its kind of changing right now.

Rajesh K. Malik: Overall survival is that. Fair or is there a PFS readout? I'm asking what, in effect, would be the primary?

Tony Butler: Yeah, so, you know, 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, you know, towards the end of next year, as I mentioned, which will likely be more response rate focused with others to follow.

And.

Thank you.

Alright. Thank you Dave I appreciate the question, yes, I think for the foreseeable future, we've really tightened and strategic aperture around trial, just given the sort of pipeline and a molecule potential that it has given us the dual benefits of both myeloid protection and anti tumor efficacy.

Rate of different tumor types, and chemo regimen, and so from a capital allocation strategy and Thats really where we are.

Rajesh K. Malik: Thanks Raj, I appreciate it. Sure.

Dane Vincent Leone: And our next question comes from the line of Dane Leone with Raymond James. Your line is open.

And we're highly focused and making sure that we both have a successful launch here and the initial indication along with.

Dane Vincent Leone: Thank you for taking the questions. Congratulations on the launch, and thank you for providing the details around that.

Obviously, Kevin Youkilis development plan and all of those studies initiative and the first half of this year FERC. So for the foreseeable future real use trial and focus obviously, we do have progressed.

John E. Bailey: I just wanted to ask more of a strategic question when we think about the company going into the launch of Trilocyclib and potentially expanding indications over the next couple of years. How do you think about other assets around that that you might think about, you know, 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 you're building?

Professor and we'll get the readout next quarter on that.

The primary focus for us is really around trial and here for the foreseeable future.

And.

Great. Thank you.

And our next question coming from the line of and your Palm Rama with Jpmorgan. Your line is open.

Hey, guys. This is pass on the call Tonight, Toronto and London.

Taking a question.

Just a quick one on the pipeline actually.

John E. Bailey: Or would you also look at, you know, more traditional assets that would be, you know, directly targeting the tumors as well? How are you thinking about the company's strategy as it's kind of changing right now? Thank you.

Sort of bridging from my prior question.

And think about the expansion data and that we're gonna get into queue. I was wondering Roger or anyone else can you go a little bit more granular.

For us.

And when looks like from a safety perspective, and then just kind of a logistical line is this is this brand to be like a PR or and medical meeting presentation. How are you thinking about that thanks. So much.

John E. Bailey: Alright, thank you Dane, appreciate the question. Yeah, I think for the perceivable future, we've really tightened the strategic aperture around trila, just given this sort of pipeline and the molecule potential that it has, given the dual benefits of both myeloprotection and anti-tumor efficacy and an array of different tumor types and chemotherapeutics. So, from a capital allocation strategy, that's really where we're highly focused on making sure that we both have a successful launch year for the initial indication, along with obviously getting this development plan, all of those studies initiated in the first half of this year. So, for the foreseeable future, it really is trila-focused. Obviously, we do have rinse or death strength. We'll get the readout next quarter on that. The primary focus for us is really around trialing for the perceivable.

Yeah, Hey, Tessa so yes.

From a from a safety perspective.

<unk> 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 Brady cardio and no.

No ocular toxicities, which had been issues and some of the other agents.

And as well as Cytopenia is so I think those are those are the safety signals, we wouldn't be looking for.

And.

And.

And we would expect to present the data at a medical meeting.

Okay, Okay, great and thanks for taking our question.

Sure.

Yeah.

And our next question coming from the line of Tom Shrader with B T. I G. Your line is now open.

Hi, This is Cary pool, and then for Tom Thanks for taking our question.

Dane Vincent Leone: Great, thank you.

For your first line trial can you tell us why you chose bladder cancer, given seasons, and Florida, Mount Sidoti and is going to be in bladder cancers down, whereas the frontline and non small cell lung cancer is more static.

Anupam Rama: Our next question comes from the line of Anupam Rama with JP Morgan. Your line is open. Yeah, guys, this is Tess on the call tonight 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 2.2, I was wondering, Raj, or anyone else, can you get a little bit more granular for us about what a WIN looks like from a safety perspective? And then, just kind of a logistical one, is this planned to be like a PR or a medical meeting presentation? How are you thinking about that?

And and a follow up on that do you plan to do a trial in combination with ADC because neutropenia is the dose limiting toxicity for almost all of them.

Yeah. Good question so regarding bladder.

Our strategic interest in that particular study was to generate data in combination with checkpoint inhibitors.

And so that was 70 and the driving force there.

Fully understand your comment about paths of past of pad so sorry.

Rajesh K. Malik: Yeah, hey, Tessa. So, yeah, from a safety perspective, you know, continued good safety profile, we were very, you know, quite favorable in terms of GI tolerability, and that's what we want to continue to see.

And that ADC. So we'll have to obviously follow that data and first line and when that matures.

Yes. Your in terms of combinations with ADC 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 and not only by improving Milo suppression, but also through this immune enhancing property.

Rajesh K. Malik: Obviously, no bradycardia, no, you know, 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.

<unk>.

Costello because at the end of the day, the ADC is chemotherapy and so that we've seen additives.

Anupam Rama: Okay, okay, great. Thanks for taking our questions. Sure.

Two gem carbo and triple negative breast cancer. So, yes, I think it makes sense definitely to combined with Adcs and we're exploring that.

Tom Schrader: And our next question comes from the line of Tom Schrader with BTIG. Your line is now open. Hi, this is Kaveri Pohlman for TOMS. Thanks for taking our question. For your first line trial, can you tell us why you chose bladder cancer, given sejans and fortum abdodin are going to be in bladder cancer soon, whereas a front line in non-small cell lung cancer is more static? And to follow up on that, do you plan to do a trial in combination with ADCs?

Got it and for a triple negative breast cancer can you talk about your rationale for not using a checkpoint inhibitor combination because that's just stomach and do some point is more immunogenic tumor and casually is already approved and the frontline setting.

Yeah.

I think it goes back to our data, where we saw activity and both PD lone positive and PD lone negative and the checkpoints are only approved and PDL one positive about 40% of the <unk>.

Kaveri Pohlman: Because neutropenia is the dose-limiting toxicity for almost all of them.

Rajesh K. Malik: Yeah, good, good question. So regarding bladder cancer, you know, our strategic interest in that particular study was to generate data in combination with checkpoint inhibitors. And so that was certainly the driving force there.

The population of metastatic triple negative breast cancer. So we wanted to enroll all comers and.

And both PDL, one positive and PDL one negative if you look at our data.

And a relatively small trial and improvement in survival, which has not been seen with either checkpoint inhibitor. So if we're able to reproduce those data and.

Rajesh K. Malik: Sorry. You know, and that ADC. So we'll obviously have to follow that data in the first line when that matures. Yes, in terms of combinations of ADCs, that is an area that we're also exploring, 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 Cocella. Because at the end of the day, the ADC is chemotherapy, so we've seen additivity to gemcarbo and triple negative breast cancer. So yes, I think it makes sense definitely to combine it with ADCs, and we're exploring that.

In fact, the combination of trailer cycle, it with chemo could even potentially be an alternative to a checkpoint inhibitor.

So that was our rationale and first line and.

And second line is post checkpoint inhibitor and given the immune mechanism of action and since trial and cycle of as a CDK <unk> inhibitor.

And it has a different immune mechanism to checkpoints. We believe there is an opportunity to see activity and the post checkpoint setting which is clearly a and.

And unmet need as well.

So that was our rationale behind the design and triple negative breast cancer, and our second and third line non small cell lung cancer study is also.

Kaveri Pohlman: Got it. And for 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 a more immunogenic tumor, and TEZO is already approved in frontline settings.

And a post checkpoint and setting.

Got it great Thanks, and congrats on the progress.

Thank you.

Yeah.

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

Rajesh K. Malik: Yeah, you know, 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, uh, you know,

Hey, Thanks for taking the questions I had two.

And I may 1st off on the bladder cancer study.

I'm curious.

Do you say.

Different than presentation, and then the triple negative where you'll have a fixed cycles of chemo, where youre planning to dose for solar and then dose with solo and <unk>.

Combination with and I O H and afterwards, so I was a little curious if there was any way to analyze or break apart the data.

Rajesh K. Malik: If you look at our data,

Rajesh K. Malik: and improvement in survival, which has not been seen with either checkpoint inhibitor. So if we're able to reproduce those data, in fact, a combination of trialocyclic 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 a post-checkpoint inhibitor, and given the immune mechanism of action, and since Trelacyclov is a CDK4-6 inhibitor, you know, it has a different immune mechanism than 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 and our second, third line non-small cell...

Potential benefit of <unk> between the as you think about the study between the chemo portion and the maintenance therapy with a belly and map and then quickly on the cash guidance into 2023, and incorporating opex only or presumed revenues. Thanks.

Yes, David.

In terms of.

That's exactly what we will do what we are interested in is to look at so for example patients got up to six cycles of gem platinum and this and this regimen and then if they have not progressed. They go onto receive a value math. So one of the things we'd be interested and looking at given our data with gem carbo and triple negative breast cancer.

Kaveri Pohlman: Great, thanks, and congrats on the progress.

Kaveri Pohlman: Thank you.

David Matthew Nierengarten: Our next question comes from the line of David Nierengarten with Red Bush Securities. Your line is open.

And do more patients actually make it to maintenance and value.

David Matthew Nierengarten: Hey, thanks for taking the questions. I had two, if I may.

And so we will be looking at that and then of course, we'll be looking at survival and.

David Matthew Nierengarten: First off, on the bladder cancer study, I'm curious, you know, obviously, it's a bit different than the triple negative presentation where you have a fixed cycle of chemo where you're planning to dose Cocella and then dose Cocella in combination with an IOH and afterwards. So I was a little curious if there was any way to analyze or break apart the data or potential benefit of Cocella between, you know, as you think about the study, between the chemo portion and the maintenance therapy with Velumab. And then quickly, on the cash guidance into 2023, is that incorporating OPEX only or presumed revenues? Thanks.

PFS across the entirety of the study, but also from the initiation of maintenance so that we can.

Have a evaluated versus the javelin data.

Because obviously that trial only that trial started from the maintenance portion because.

All the patients who made it.

Onto a value map or included in that trial. So we yes, we will be looking at the trial overall and breaking it apart and to those two components.

Yeah.

And David It's John.

On the runway when we're looking at we actually have a number of ways to get into 2023, and and being kind of cautious saying into 'twenty and 'twenty three and now giving further guidance on it. So if you look at the cash balance we have after the ATM and you look at the ability to draw down debt. Even if we just look at that $30 million that's still that's available.

Rajesh K. Malik: Yeah, David. So in terms of us, that's exactly what we will do. What we're interested in looking 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 value map. So one of the things we'd be interested in looking at, given our data with Gem Carbo and triple negative breath cancer, is whether more patients actually make it to the maintenance value map.

Right now, although we will we are expecting some 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 and with a range of revenues and still feel very comfortable giving guidance into 2023.

Okay got it thank you.

And 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.

Rajesh K. Malik: OK.

Rajesh K. Malik: and so we will be looking at that and, of course, survival and PFS across the entirety of the study but also from the initiation of maintenance so that we can compare it to the javelin data because obviously, that trial only started from the maintenance phase because only patients who made it onto a value map were included in that trial, so we yes

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 'twenty and 'twenty. One we are excited to bring to sell with a patient 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.

Rajesh K. Malik: Yes, we'll be looking at the trial overall.

Rajesh K. Malik: and breaking it apart into those two components.

Yeah.

Jen Moses: David, it's Jen. So on the runway, when we're looking at it, we actually have a number of ways to get into 2023. And I'm being kind of cautious saying into 2023 and not giving further guidance on it. So if you look at the cash balance we have after the ATM, you look at the ability to draw down debt, even if we just look at that $30 million that's available right now. Also, 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 feel very comfortable giving guidance into 2023.

Ladies and gentlemen that does conclude the conference for today. Thank you for your participation you may all disconnect.

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David Matthew Nierengarten: Okay, I got it. Thank you.

John E. Bailey: 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.

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Operator: 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 Coacella 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.

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Operator: Ladies and gentlemen, that does conclude our conference for today. Thank you for your participation. You may all disconnect.

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