Q2 2021 G1 Therapeutics Inc Earnings Call

August 4, 2021

[music].

Operator: Good day, thank you for standing by, and welcome to the G1 Therapeutics 2nd Quarter 2021 Financial Results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host, Mr. Will Roberts. Please go ahead, Gil.

Good day, Thank you for standing by and welcome to the G..1 therapeutics second quarter 2021 financial results conference call. At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time, if anyone should require assistance do you mean.

The conference. Please press Star then zero on Hitachi <unk> telephone I would now like to turn the conference over to your host Mr. Weil Roberts. Please go ahead Sir.

Operator: Thank you, Les. Good afternoon, everyone, and welcome to the G1 conference call to discuss our session.

Thank you Laura.

Good morning, everyone and welcome to the Q1 conference call to discuss our second quarter 2021 financial results and business update.

Operator: or Financial Results and Business Update

Operator: The press release on these financial results was issued after market closed this afternoon and can be found in the news section of our corporate website, G1Therapeutics.com On this call, the team will provide a business overview of the second quarter of 2021, including an update on our launch progress in that period with Cocella, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myeloid suppression in adult patients when administered prior to a platinum methoxide-containing regimen or to a fatigue-containing regimen for extensive stage small cell lung cancer, or ESSCLC, and became available in the channel in early March of 2021. A question and answer session will follow the prepared remarks. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

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

On this call the team will provide a business overview of the second quarter of 2021, Inc.

<unk> an update on our launch progress in that period with Castilla.

Which was approved by the U S food and drug administration on February 12, 2021 to decrease the incidence of chemotherapy induced smile with depression and adult patients when administered prior to the platinum as herbicide containing regimen for total chicken containing regimen for extensive stage small cell lung cancer for Es SCLC and became available.

And the channel in early March of 2021.

A question and answer session will follow the prepared remarks.

Before we begin I want to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Operator: Such statements represent management's judgment as of today.

Such statements represent managements judgment as of today.

And may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.

For more information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website.

Operator: Please refer to our filings with the security authorities.

Operator: for more information, which is available from the SEC or online.

Operator: Any forward-looking statements that represent our views as of today?

Any forward looking statements represent our views as of today August for 2021.

Operator: As of today, August 4, 2021.

Operator: Joining me on the call today are Jack Bailey, our Chief Executive Officer; Jen Moses, our Chief Financial Officer; and Raj Malik, our Chief Medical Officer.

Joining me on the call today are Jack Bailey, our Chief Executive Officer, Jen Moses, our Chief Financial Officer, and Raj Malik Chief Medical Officer.

Operator: medical office. With that, I'll turn the call over to Jack.

With that I'll turn the call over to Jack Jack Thanks for.

John E. Bailey: Thanks, Will. Good afternoon, everyone, and thank you for joining us on the call today. Today's headline from the second quarter is one of a continued focus on execution, both as it relates to our early readout of our ongoing commercial launch of Costella and as it relates to our clinical program. I joined G1 because of our shared commitment to improve the lives of people impacted by cancer. This core mission is tangible at G1, and I am confident in the G1 team as we seek to help as many people with cancer as we can and drive long-term value for our shareholders.

Good afternoon, everyone and thank you for joining us on the call today.

Today's headline for the second quarter is 1 of a continued focus on execution both as it relates to our early readout of our ongoing commercial launch of <unk> and as it relates to our clinical programs.

Now I joined Q1, because of our share commitment to improve the lives of people impacted by GM Sir.

This core mission to tangible at G..1 and I am confident in the <unk> as we seek to help as many people with cancer as we can and drive long term value for our shareholders.

John E. Bailey: We believe Cocella is a paradigm-changing drug. It is the first and only multilineage myeloprotection therapy to offer proactive protection against the dangerous impacts of myelosuppression when treating small cell lung cancer patients with certain chemotherapy regimens. It allows oncologists treating small cell lung cancer patients to move away from treating significant mitral suppressive side effects individually with different drugs after the damage has been done and instead, enabling them to help decrease or prevent the occurrence of these side effects altogether with the proactive use of a single therapy.

We believe co sell it as a paradigm changing drug it.

It is the first and only multi lineage maiolo protection therapy to proactive protection against the interest impact of mindless suppression, when treating small cell lung cancer patients with certain chemotherapy regimens.

It allows oncologists treating small cell lung cancer patients to move away from treating significant Michael suppressive side effects individually with different drugs. After the damage has been done to instead, enabling them to help decrease will prevent the occurrence of these side effects altogether with the.

Proactive use of a single therapy.

John E. Bailey: And during the second quarter, we continued to lay the groundwork for broad commercial access to Costella as we made progress toward our long-term goal of ensuring the availability of this important drug. But we also remain equally focused on Cosella's next indication. During the second quarter, we initiated three new clinical trials with Cocella, including a registrational trial in metastatic triple negative breast cancer and two phase two trials in patients with non-small cell lung and bladder cancer.

And during the second quarter, we continued to lay the groundwork for broad commercial access to Castella as we made progress toward our long term goal of ensuring the availability of this important truck.

But we also remain equally focused on <unk> next indications during the second quarter, we initiated 3 new clinical trials with <unk>, including a registrational trial in metastatic triple negative breast cancer and 2 phase III trials in patients with non small cell lung.

Bladder cancer.

John E. Bailey: This is in addition to the pivotal trial in colorectal cancer dosing, which was initiated in the first quarter. So in total, we now have two phase three registrational trials and three phase two trials ongoing with multiple rehouse starting in the second half of 2022. Now, we have a lot of important content to cover today.

This is in addition to the pivotal trial in colorectal cancer dosing for which was initiated in the first quarter.

So in total we now have 2 phase III Registrational trials and 3 phase II trials ongoing with multiple readouts starting in the second half of 2022.

Okay.

And we have a lot of important content to cover today.

I will cover our commercial efforts for the second quarter of 2021, the first full quarter of cross sell of sales and also provide an update on our leading and lagging indicators of cross sell on access and uptake that we introduced on the last call.

John E. Bailey: I will cover our commercial efforts for the second quarter of 2021, the first full quarter of Coastella sales, and also provide an update on the leading and lagging indicators of Coastella access and uptake that we introduced on the last call. Raj will then provide an update on some of our medical efforts and clinical milestones during the second quarter. He will also touch on the upcoming trial that we expect to initiate in the fourth quarter of this year designed to further define the immune-based anti-tumor mechanism of action of Cocella.

<unk> will then provide an update on some of our medical efforts and clinical milestones during the second quarter. He will also touch on the upcoming trial that we expect to initiate in the fourth quarter of this year designed to further define the immune based anti tumor mechanism of action of <unk>.

Finally, Jim will provide the financial results for the quarter, then I'll be back for some concluding comments.

Now before we discuss our results for the quarter you likely saw that on Monday, we announced that Soma Gupta left the organization for personal and professional region.

John E. Bailey: Finally, Jen will provide the financial results for the quarter, then I'll be back for some concluding comments. Now, before we discuss our results for the quarter, you probably saw that on Monday we announced that Soma Gupta left the organization for personal and professional reasons.

We appreciate her contributions to the planning and the launch of Casella and certainly wish her the best going forward.

We also announced at the same time that we have hired a new chief commercial officer, Andrew Perry for former Vice President U S marketing, a deep health care North America joint venture majority owned by Glaxosmithkline Gil.

John E. Bailey: We appreciate her contributions to the planning and the launch of Costella and certainly wish her the best going forward. We also announce at the same time that we have hired a new Chief Commercial Officer. Andrew Perry is the former Vice President, U.S. Marketing at Veeve Healthcare North America, a joint venture majority owned by GlaxoSmithKline. He is a proven leader and strategist with a history of driving consistent performance and commercial success and has tremendous commercial experience across a wide variety of specialties, including oncology, especially in areas including commercial launch strategy, execution, and co-promotion management. Andrew starts on August 16th, and I really look forward to having all of you meet him at our next business update.

He is a proven leader and strategist with a history of driving consistent performance and commercial success and has tremendous commercial experience across a wide variety of specialties, including oncology, especially in areas, including commercial launch strategy execution and co promotion management and true starts on August <unk>.

Steve and I really look forward to having all of you on our next business update.

Now turning our attention first to the commercial update the launch efforts of the combined G..1 and beringer ingelheim commercial team during the quarter resulted in us booking $2.5 million in net sales of co sell up for the quarter ending June 30 day.

Much of the last 3 months was spent with various community practices and hospital systems to gain inclusion on formulary in order sets and this will remain a key focus for the coming months as well.

For those not familiar with the process of formulary inclusion.

It's multi step requiring doctor advocacy and a practice or institution, having a successful.

Scheduled and decision take them and then where they exist incorporation into EHR order sets.

John E. Bailey: Now, turning our attention first to the commercial update, the launch efforts of the combined G1 and Beringer Ingelheim commercial team during the quarter resulted in us booking $2.5 million in net sales of Coacella for the quarter ending June 30th. Much of the last three months has been spent with various community practices and hospital systems to gain inclusion on formulary and order sets, and this will remain a key focus for the coming months as well.

It's worth noting that this year, primarily due to the slow open other country. We have seen a number of these planned meetings postponed which can affect the speed of uptake.

On our last call, we set up a variety of leading and lagging indicators to help you follow our progress quarter over quarter, which I will now cover.

I'll focus on 4 key areas awareness coverage and reimbursement engagement and utilization.

Now for awareness, both aided and unaided are solid.

As of the end of June our unaided awareness or awareness of casella without specific prompts was at 56% in.

John E. Bailey: For those not familiar with the process of formulary inclusion, it's multi-step, requiring doctor advocacy in a practice or institution, having a successful P&T scheduled and decision taken, and then, where they exist, incorporation into EHR order sets. It's worth noting that this year, primarily due to the slow opening of the country, we have seen a number of these planned P&T meetings postponed, which can affect the On our last call, we set up a variety of leading and lagging indicators to help you follow our progress quarter over quarter, which I will now cover. I'll focus in on four key areas: awareness, coverage, and reimbursement, engagement, and utilization. Now for awareness, both aided and unaided are solid.

And aided awareness based upon questions on familiarity with co sell it in syndication was at 77%. These are both above benchmark for this point in an oncology product launch.

Ah regarding coverage and reimbursement all other payers have been covering casella with written to label.

Approximately 60% is Medicare part D, 30% is commercial and the remaining 10% is government and other forms of coverage.

And we now have payer policies in place or pending that provide coverage for approximately 80% of on label patient lives.

3 of the top 5 U S payers have made positive coverage decisions within the first 4 months of product availability.

Most importantly, we are not seeing any pushback in terms of reimbursement of final claims.

We have had formulary approval at 18 of our top 100 organizations in 'twenty 1 organizations have proceeded with inclusion of cross sell it into their order sets.

All of our top 100 organizations have a beauty process for us and some are still determining how to incorporate for sell it into their orders and we expect additional approvals over the coming months.

John E. Bailey: As of the end of June, our unaided awareness, or awareness of Cocella without specific prompts, was at 56%, and aided awareness based upon questions on familiarity with CoCell and its indication was at 77%. These are both above benchmark for this point in an oncology product launch. Now regarding coverage and reimbursement, all of the payers have been covering Coacella when written to label. Approximately 60% is Medicare Part B, 30% is commercial, and the remaining 10% is government and other forms of coverage.

Now as you May recall, we filed for our C code and permanent J code in March and we recently received both our C code for pass through hospital outpatient system use became effective on July 1 and our permanent J code for all sites of care across all channels will become effective October.

For 1.

As you saw this morning, we were just issued a new technology add on payment or untapped for Costello.

We'll also become effective for provider billing on October 1.2021.

<unk> is an important tool that provides additional payments to hospitals above the standard DRG payment model.

Moving onto an engagement perspective as of the end of June the team has achieved approximately 53% reach to 2500 targeted hcp's and made an additional nearly 4000 targeted calls to other prescription enabling functions such as nurses and pharmacists.

John E. Bailey: And we now have payer policies in place or pending that provide coverage for approximately 80% of unlabeled patient lives. Three of the top five U.S. payers have made positive formal coverage decisions within the first four months of product availability. Most importantly, we are not seeing any pushback in terms of reimbursement of filed claims.

For our critical stakeholders in the supportive care space.

At the end of Q2, almost 60% of these calls we're still virtual.

And while we believe the ratio of in person to virtual calls will improve over time, we don't yet know how quickly for how many institutions will remain virtual in a post COVID-19 environment.

John E. Bailey: We've had formulary approval at 18 of our top 100 organizations, and 21 organizations have proceeded with the inclusion of CoStella into their order sets. However, not all of our top 100 organizations have a P&T process for use, and some are still determining how to incorporate Cocella into their order sets. We expect additional approvals over the coming months. Now, as you may recall, we filed for our C-code and permanent J-code in March, and we recently received both.

As some of our oncology peer companies have recently stated the average.

Apology category is lagging most other therapeutic areas many of which were approaching pre COVID-19 levels.

This is a macro issue issue, which we are closely monitoring as we head into the next few months.

This also underscores the continued maturation of our virtual capabilities will continue to be vital as this will be an increasingly important and expected way to reach many in our target audience.

From a utilization perspective in the second quarter, 70% of our demand came from community hospitals or clinics with the remaining 30% coming from academic hospitals.

John E. Bailey: Our C-code for pass-through hospital outpatient system use became effective on July 1, and our permanent J-code for all sites of care across all channels will become effective on October 1. And, as you saw this morning, we were just issued a new technology add-on payment, or NTAP, for Coacella. It will also become effective for provider billing on October 1st, 2021. The NTAP is an important tool that provides additional payment to hospitals above the standard DRG payment.

We received orders from 68 unique organizations up from 20 at the end of March.

<unk> 28 of those are from our top 100 priority organizations again up from 7 debt.

At the end of March.

These priority organizations are essential to not only driving the breadth or trial or co sell up into the community and hospital accounts across the U S. But also the depth or number of positions in any given practice using a drug and encouraging others to do so.

At this point the breadth of adoption to date of <unk> is directionally correct.

John E. Bailey: Moving on to an engagement perspective, as of the end of June, the team achieved approximately 53% reach to our 2,500 targeted HCPs and made an additional nearly 4,000 targeted calls to other prescription-enabling functions, such as nurses and pharmacists, who are critical stakeholders in the supportive care space. However, at the end of Q2, almost 60% of these calls were still virtual. And while we believe the ratio of in-person to virtual calls will improve over time, we don't yet know how quickly or how many institutions will remain virtual in a post-COVID world.

We are increasing our efforts to drive depth across these accounts.

Now before I close I want to comment on some things we are seeing in the channel in the third quarter.

We have seen some recent softness in orders, which we believe is addressable.

Just heard the performance metrics for the second quarter, our solid despite a slower than ideal opening of the country. We have good awareness for product is performing clinically as expected physician experience with the drug is excellent and we have encouraging data that shows accounts that trial the drug are embracing it so strong.

Non-GAAP can be achieved.

Our breath as I've said, it's directionally correct, but driving depth is the next challenge we have some regions of the country that are outperforming on this dimension. However, others are underperforming we will look to address this and drives more consistent and stronger execution across the country in all regions.

John E. Bailey: As some of our oncology peer companies have recently stated, the oncology category is lagging most other therapeutic areas, many of which are approaching pre-COVID levels. This is a macro issue which we are closely monitoring as we head into the next few months. This also underscores that continued maturation of our virtual capabilities will continue to be vital, as this will be an increasingly important and expected way to reach many in our target audience.

So to summarize our net sales for the second quarter were just over $2.5 million, both aided and unaided awareness are up baseline for a product like this.

We have moved through several operational hurdles for example, the <unk> guidelines and payer reviews, while still having many PMT processes, yet to complete we have seen no issues in coverage and reimbursement and where you're at.

John E. Bailey: From a utilization perspective, in the second quarter, 70% of our demand came from community hospitals or clinics, with the remaining 30% coming from academic hospitals. We received orders from 68 unique organizations, up from 20 at the end of March.

We have received our sic code permanent J code and then tap with the latter 2 being effective on October 1 of this year.

We will continue to monitor the impact of COVID-19 variance on the opening of our target community practices and hospital systems and their willingness to receive reps into their offices.

And while in person selling is important and also likely more critical for our volume Bill sell like for seller, we intend to remain as effective as possible even in a virtual sales environment.

John E. Bailey: Twenty-eight of those are from our top 100 priority organizations, again, up from seven that had ordered at the end of March. These priority organizations are essential to not only driving the breath or trial of Cocella into the community and hospital accounts across the U.S. but also the death or number of physicians in any given practice using a drug and encouraging others to do so. At this point, the breadth of adoption to date of Cocella is directionally correct.

And we will continue to evolve and improve our virtual capabilities going forward now.

Now with that I'll turn it over to Raj for an update on our medical and clinical efforts during the second quarter Raj.

Thanks, Jack and good afternoon, everyone I am going to cover 3 topics first I will provide a brief update on a few of our medical affairs efforts during the quarter.

Ill then provide an overview of the 2 phase III trials, we initiated in the second quarter.

And I'll introduce a new trial that we intend to initiate for the end of this year.

John E. Bailey: However, we are increasing our efforts to drive depth across these areas. Now, before I close, I want to comment on some things we are seeing in the channel in the third quarter. We have seen some recent softness in orders, which we believe is addressable. As you just heard, the performance metrics for the second quarter are solid, despite a slower-than-ideal opening of the country. We have good awareness, the product is performing clinically as expected, position experience with the drug is excellent, and we have encouraging data that shows accounts that are trialing the drug are embracing it, so strong depth can be achieved.

Assigned that designed to further define the mechanism of action of Casella.

It's a small study of 1 debt, we expect to generate a tremendous amount of important data.

From a medical affairs perspective, we continued to execute on our medical communications plan during the second quarter, which includes ensuring broad visibility of our data among the medical community and identifying avenues for scientific dialogue.

For example, during the quarter, we presented data and had a presence at virtual at light meetings, including the International Society for Pharmacodynamics and outcomes research or <unk> meeting at <unk>.

At <unk>, we presented 2 posters, describing the estimated economic impact of treating modest depression, among patients with extensive stage small cell lung cancer.

A particular interest during the meeting was our poster that provided a cost benefit model estimating the economic value of using cost prior to chemotherapy in extensive stage small cell lung cancer from a U S commercial payer perspective.

John E. Bailey: Our breath, as I said, is directionally correct, but driving depth is the next challenge. We have some regions of the country that are outperforming on this dimension, but others are underperforming. We will look to address this and drive more consistent and stronger execution across the country in all regions. So, to summarize, our net sales for the second quarter were just over $2.5 million. Both aided and unaided awareness are above baseline for a product like this.

The projected estimated total cost savings for them.

Patient is approximately $15000.

On a projected reduction in mila suppressive adverse events and their associated treatment costs with on label use.

Overall, the model indicates that a seller is an economically favorable innovation when addressing the incidents of modest depression in patients with extensive stage small cell lung cancer.

John E. Bailey: We have moved through several operational hurdles, for example, the MTCN guidelines and payer reviews, while still having many P&T processes yet to complete. We have seen no issues with coverage and reimbursement, and we have received our C-code, permanent J-code, and NTAP, with the latter two being effective on October 1st of this year. We will continue to monitor the impact of COVID-19 variants on the opening of our target community practices and hospital systems and their willingness to receive reps into their offices.

We were also very active at <unk>.

Presenting posters interact with interacting with key opinion leaders in oncology via our virtual booth and sponsoring a peer view CME program called long awaited treatment advances and cause for optimism in small cell lung cancer.

Finally, as I mentioned on the last call since the approval of <unk>. We've had marked interest in our scientific platform and real world evidence generation.

We've been pleased and the interest in our investigator initiated study program and some of these studies will start later this year.

John E. Bailey: And while in-person selling is important, and also likely more critical for a buy-and-bill sale like Cosella, we intend to remain as effective as possible, even in a virtual sales environment, and will continue to evolve and improve our virtual capabilities going forward. Now, with that, I'll turn it over to Raj for an update on our medical and clinical efforts during the second quarter.

Additionally, we are working with oncology centers, so that they can assess the burden of chemotherapy induced model suppression in their own practice.

Switching now to clinical trial progress.

Colorectal trial is ongoing and we initiated 3 new trials during the second quarter we.

We discussed the phase III triple negative breast cancer trial on our last call. So I'll discuss the 2 phase twos today.

Rajesh K. Malik: Thanks, Jack, and good afternoon, everyone. I'm going to cover three topics. First, I will provide a brief update on a few of our medical affairs efforts during the quarter. I'll then provide an overview of the two Phase II trials we initiated in the second quarter. And I'll introduce a new trial that we intend to initiate before the end of this year, designed to further define the mechanism of action of Cocella. It's a small study, but one that we expect to generate a tremendous amount of important data.

In May we initiated preserved for a multicenter randomized double blind placebo controlled phase II study of Casella administered prior to Docetaxel in approximately 146 patients with metastatic non small cell lung cancer in the second and third line setting who have.

Previously been treated with a checkpoint inhibitor and chemotherapy.

Non small cell lung cancer is the most common type of lung cancer accounting for 84% after nearly 240000 non.

Rajesh K. Malik: From a medical affairs perspective, we continue to execute on our medical...

Non cash of diagnosis in the United States.

For people diagnosed with metastatic disease, a 5 year survival rate is only 7%.

Rajesh K. Malik: communications plan during the second quarter, which includes ensuring broad visibility of our data among

And unfortunately, despite improvements in therapy for metastatic non small cell lung cancer, including the use of PD, 1 or PD lone inhibitors. The majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy.

Rajesh K. Malik: among the medical community and identifying avenues for scientific research

Rajesh K. Malik: For example, during the quarter, we presented data and had a presence at virtual and live meetings, including the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, meeting and ASCO. At ISPOR, we presented two posters describing the estimated economic impact of treating myelosuppression among patients with extensive stage small cell lung cancer. Of particular interest during the meeting was our poster that provided a copy...

The primary endpoint of the trial is to evaluate the effect of casella on overall survival compared to placebo.

Secondary endpoints will evaluate antitumor efficacy and the multi lineage malware protection benefit of casella compared to placebo has at our other trials and we'll also assess safety.

We expect to see interim data in the first half of 2023.

Rajesh K. Malik: This is a cost-benefit model estimating the economic value of using Cocella prior to chemotherapy in extensive-stage small-cell lung cancer.

Next in June we initiated preserved 3 a phase III randomized open label study of course setup administered with first line platinum based chemotherapy and immune checkpoint inhibitor or a value map as maintenance therapy, and approximately 90 patients with untreated locally advanced or <unk>.

Rajesh K. Malik: lung cancer from a U.S. commercial payer perspective. The projected estimated total cost savings per patient is approximately $15,000 based on a projected reduction in myelosuppressive adverse events and their associated treatment costs with on-label use.

Static urothelium, our bladder carcinoma.

There are approximately 84000, new cases of bladder cancer every year and unfortunately, the overall 5 year survival rate for metastatic bladder cancer is under 6% a number that has not improved in the past 25 years.

Rajesh K. Malik: Overall, the model indicates that Costella is an economically favorable innovation when addressing the incidence of model suppression in patient care.

Rajesh K. Malik: and Patients with Extensive Stage Small Cell Lung Cancer. We were also very active at ASCO, presenting posters, interacting with key opinion leaders in oncology via our virtual booth, and sponsoring a peer-reviewed CME program called Long-Awaited Treatment Advances Give Cause for Optimism in Small Cell Lung Cancer. Finally, as I mentioned on the last call, since the approval of Cosella, we've had marked interest in our scientific platform and real-world evidence generation.

Patients are being randomly assigned 1 to 1 to 1 of 2 treatment arms in 1 arm they will receive gemcitabine platinum chemotherapy for.

Followed by a value mark maintenance therapy.

And the other arm.

To receive casella prior to chemotherapy, followed by <unk>, plus a value Bob maintenance therapy.

The primary endpoint is to evaluate progression free survival during the overall study.

Key secondary endpoints evaluate other measures of antitumor efficacy.

Rajesh K. Malik: We've been pleased with the interest in our investigator-initiated study program, and some of these studies will start later this year.

We will also evaluate the multi lineage model protective effects of casella on chemotherapy induced model suppression and safety.

Rajesh K. Malik: Additionally, we are working with oncology centers so that they can assess the burden of chemotherapy-induced tumor suppression in their own practice.

We expect to see data in the second half of 2022.

Finally, as we develop casella in the clinic, we must continually ensure that we conduct trials that we believe will maximize the value of cassava.

Rajesh K. Malik: Switching now to a clinical trial.

Rajesh K. Malik: Our colorectal trial is ongoing, and we initiated three new trials during the second quarter. We discussed the Phase III triple-negative breast cancer trial on our last call, so I'll discuss the two Phase IIs today.

I am happy to announce an upcoming phase II trial that we believe will help to do exactly that.

The trial is designed to evaluate the immune based anti tumor mechanism of action of Casella.

By assessing changes in the tumor microenvironment after administration of Kosovo.

And this clinical study in patients with early stage triple negative breast cancer will be looking at changes in the ratio of CD 8 T cells to T regulatory cells in the tumor microenvironment.

Rajesh K. Malik: In May, we initiated PRESERVE IV, a multicenter, randomized, double-blind, placebo-controlled phase 2 study of Cocella administered prior to docetaxel in approximately 146 patients with metastatic non-small cell lung cancer in the second and third line setting who have previously been treated with a checkpoint inhibitor and chemotherapy. Non-small cell lung cancer is the most common type of lung cancer, accounting for 84% of the nearly 240,000 lung For people diagnosed with metastatic disease, the five-year survival rate is only 7%.

Long with a variety of other assessments of immune function following treatment with casella to further define what we believe is a broadly applicable mechanism of action.

We expect to announce initiation of this trial later this year and we will provide more detail on the trial design at that time.

Before I conclude I'll briefly comment on our recent fast track designation for Casella in combination with chemotherapy in triple negative breast cancer.

This is important as drugs with fast track designation are eligible for more frequent engagements with the FDA to discuss the clinical development plan.

Rajesh K. Malik: And unfortunately, despite improvements in therapy for metastatic non-small-cell lung cancer, including the use of PD-1 or PD-L1 inhibitors, the majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy. The primary endpoint of the trial is to evaluate the effect of Cocella on overall survival compared to placebo. Secondary endpoints will evaluate anti-tumor efficacy and the multilinear...

<unk> approval pathways and priority review and rolling NDA submission, allowing us to submit completed sections of an NDA to FDA on a rolling basis.

We look forward to working closely with the FDA as we advance <unk> through this ongoing pivotal program.

With that I'll turn the call over to Chen for a re.

Our view of the financial results for the second quarter of 2021 Jen.

Thanks, Raj and good afternoon, everyone as will mentioned full financial results for the second quarter of 2021 are available in our press release and 10-Q today I will focus on a few key points from our disclosures.

Rajesh K. Malik: We will assess risk of asthma compared to placebo, as in our other trials, and we'll also assess safety. We expect to see interim data in the first half of 2022. Next, in June, we initiated PRESERVE III.

Our total revenue for the second quarter 2021 was $6.6 million comprised of net product revenue of $2.5 million and license revenue of $4.1 million.

For net product revenue, we realized the growth to net percentage in the mid teens and expect to realize the growth to net percentage in the mid to high teens going forward.

Rajesh K. Malik: Phase II Randomized Open-Label Study of...

Rajesh K. Malik: study of Cosella administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor Avelumab as maintenance therapy in approximately 90 patients with untreated locally advanced or metastatic urothelial or bladder carcinoma. Unfortunately, the overall five-year survival rate for metastatic bladder cancer is under 6%, a number that has not improved in the past 25 years. Patients are being randomly assigned one-to-one to one of two treatment arms.

The main driver variability in our gross to net adjustment is our percentage of sales to <unk> the organization.

Our license revenue was primarily related to a $3 million development milestone payments from our license agreement with <unk>, specifically related to the initiation of the bridging study a trial of <unk> in first line and second and third line extensive stage small cell lung cancer.

We benefit from the <unk> partnership in a variety of ways.

This includes financial benefits, such as current and future milestones and royalties.

We have also discussed our ability to participate in our clinical trial.

<unk> participating in both our CRC and CNBC studies, which we believe will help not only control cash burn on these studies, but also provide additional site to help us continue to enroll this trial at an appropriate pace.

Rajesh K. Malik: In one arm, they will receive Gemcitabine Platinum chemotherapy.

Rajesh K. Malik: followed by a Value Map Maintenance Therapist. In the other arm, they will receive Cosella prior to chemotherapy, followed by Cosella plus a value-added maintenance therapy. The primary endpoint is to evaluate progression-free survival during the overall study, while key secondary endpoints evaluate other measures of anti-tumor efficacy.

Cost of goods sold for the 3 months ended June $32021.8 million.

As a reminder, the majority of the manufacturing costs related to consumer sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. These previously expense costs will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is depleted.

Rajesh K. Malik: We will also evaluate the multilineage myeloprotective effects of Cocella on chemotherapy-induced myelosuppression and safety. We expect to see data in the second half of 2020. Finally, as we develop Costella in the clinic, we must continually ensure that we conduct trials that we believe will maximize the benefits of the drug.

And additional inventory is manufactured and sold.

<unk> research and development expenses for the second quarter of 2021 were $18.8 million compared to $18.5 million for the second quarter of 2020.

Increase in R&D expenses was primarily due to an increase in clinical trials.

Offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredient and drug product to support clinical trials as well as a decrease in external costs related to discovery and preclinical development.

Rajesh K. Malik: Maximize the value of Costella. I'm happy to announce an upcoming Phase 2 trial that we believe will help to do exactly that. The trial is designed to evaluate the immune-based antitumor mechanism of action of Casella by assessing changes in the tumor microenvironment after administration of Casella.

Our selling general and administrative expenses for the second quarter of 2021 for $25.2 million compared to $14.4 million for the second quarter of 2020.

The increase in SG&A expense was largely due to an increase in commercialization activities and an increase in compensation due to increases in head count and increased spend on information technology professional services and other administrative costs.

Rajesh K. Malik: In this clinical study, in patients with early-stage triple-negative breast cancer, we'll be looking at changes.

Rajesh K. Malik: in the ratio of CD8 T-cells to T-regulatory cells in the tumor microenvironment, along with a variety of other assessments of immune function following treatment with Cocella to further define what we believe is a broadly applicable mechanism.

We ended the second quarter with cash and cash equivalents of $244 million and we expect our current financial position to be sufficient to fund operations into 2023 with that I'll turn the call back over to Jack for some closing comments.

Rajesh K. Malik: An applicable mechanism of action.

Rajesh K. Malik: We expect to announce the initiation of this trial later this year, and we will provide more detail on the trial design at that time. Before I conclude, I'll briefly comment on our recent fast-track designation for Cocella in combination with chemotherapy for triple negative breast cancer. This is important, as drugs with Fast-Track designation are eligible for...

Thank you Jen Roger will now before we close the call I want to as always thank for people living with cancer for their inspiration as we know we're only a couple of days past the world lung cancer data I'd like to specifically knowledge those families who have experienced the impact of lung cancer past and present and the important work that for.

Graphic oncologist with apology nurses and their staffs do to care for people living with it.

Rajesh K. Malik: for more frequent engagements with the FDA to discuss a clinical development plan, potential approval pathways, and priority review; enrolling NDA submission, allowing us to submit completed sections of an NDA.

We are well aware of the importance of the work we are doing at Q1 for patients with lung cancer and that there's a great need for this first and only proactive multi lineage Milo protection truck.

Rajesh K. Malik: to FDA on a rolling basis. We look forward to working closely with the FDA as we advance Cosella through this ongoing pivotal program. With that, I'll turn the call over to Jen for a review of the financial results for the second quarter of 2021.

Now before we move to Q&A, let me just recap what you've heard today for.

The combined commercial team is heavily focused on executing the plan in the second quarter and took early steps forward getting co sell a widely tried and adopted over the long term.

Jen Moses: Thanks, Raj. And good afternoon, everyone. As Will mentioned, full financial results for the second quarter of 2021 are available in our press release and 10k. Today, I will focus on a few key points from our disclosures.

No issues with reimbursement, we continue to hold a majority of our sales calls virtually we do expect that to change over time. However, as the U S continues to open up but we will monitor the impact of Covid variance in instances, where our target organizations day virtual we will continue to adapt to ensure that we are reaching them.

Jen Moses: Our total revenue for the second quarter of 2021 was $6.6 million.

Secondly, as possible.

We initiated 3 new trials in the second quarter, a phase III Registrational trial in metastatic triple negative breast cancer, and 2 phase II trials in patients with non small cell lung and bladder cancer.

Jen Moses: comprised of net product revenue of $2.5 million and license revenue of $4.1 million. For net product revenue, we realized a growth-to-net percentage in the mid-teens and expect to realize a growth-to-net percentage in the mid- to high-teens going forward. The main driver of variability in our growth-to-net adjustment is our percentage of sales to PHS organizations.

We also expect to initiate a new phase III trial later this year to further define the anti tumor mechanism of action of <unk>.

As a result, we expect to have numerous data readouts starting in the second half of next year.

We've recently received fast track designation for Casella in Triple negative breast future, which is a regulatory pathway used to give important new drugs for the patient earlier by providing regulatory support and other benefits and finally, our cash runway guidance is unchanged from our last set of guidance taking us into 2020.

Jen Moses: Our license revenue was primarily related to a $3 million development milestone payment from our license agreement with SymSeer, specifically related to the initiation of their bridging study of Trilocyclib in first-line and second- and third-line extensive-stage small cell lung cancer. We benefit from this sincere partnership in a variety of ways. Of course, this includes financial benefits such as current and future milestones and royalties, but we have also discussed their ability to participate in our clinical trials.

Thank you for your time. This afternoon, we will speak again in this format on the November call go I'm sure. We'll see many of you before then during the late summer and fall slate of virtual health care conferences and non deal Roadshows hopefully we can see many of you in person in due time as well with that I'll close the call and turn it over to Q&A.

Operator would you please remind our listeners how to ask for questions.

Thank you, Sir and as a reminder to ask a question. Please press the star and the number 1 key our net touchstone telephone. Thank for your question has been answered or you wish to remove yourself from the queue. Please.

Jen Moses: Thank you for participating in both our CRC and TNBC studies, which we believe will help not only control cash burn on these studies but also provide additional sites to help us continue to enroll this trial at an appropriate pace. Cost of goods sold for the three months ended.

Okay.

Your first question comes from the line of Chad Messer from Needham <unk> Company. Your line is open.

Jen Moses: and June 30, 2021 with $0.8 million.

Yes.

Okay.

Jen Moses: As a reminder, the majority of the manufacturing costs related to Coacella sales were incurred prior to FDA approval, and therefore were recorded as R&D expense in prior periods. These previously expensed costs will continue to impact the presentation of cost of goods sold in future periods until initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. G1's research and development expenses for the second quarter of 2021.

Good evening.

Congrats on.

Solid quarter for.

<unk>.

Got a lot of milestones being met.

I'm wondering if you could educate us a little bit for there on the importance of the <unk> decision that you reported this morning.

If there was.

And actual amounts that's sort of a maximum reimbursement amount that was.

Given.

Jen Moses: or $18.8 million, compared to $18.5 million.

This is my own EBIT, but maybe you can put some perspective on that and maybe talk about that importance as well.

Jen Moses: For the second quarter of 2020, The increase in R&D expenses was primarily due to an increase in clinical trial spend, which was offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug products to support clinical trials, as well as a decrease in external costs related to discovery and preclinical development. Selling general and administrative expenses for the second quarter of 2021 were $25.2 million compared to $14.4 million for the second quarter of 2020. The increase in SG&A expense was largely due to an increase in commercialization activities and an increase in compensation due to...

If there's any more you can say about that.

C J.

J codes withdrawal.

Recently.

Granted.

Obviously at this point in the launch.

Getting reimburse us.

Yes.

A pretty major factor to uptake.

Yes, Thanks, Chad I appreciate the questions.

When you look at both the untapped for C code and the J code on moving all speaks to frankly, what we would view as a very positive reimbursement environment. All of those of course are via CMS.

We also have the commercial market, which as we mentioned.

Every payer is allowing claims for cross sell it to flow through according to label and several have written formal policies. So I think it all speaks to to your point what is normally 1 of the biggest concerns early in our product launch is coverage and reimbursement we feel very very good my personal experience.

Jen Moses: increases in headcount, an increased spend on information technology, and professional services.

So this is as good as I've seen it in probably a decade or effective in the half for new product, whether it's commercial or Medicare patients now in terms of the untapped itself, it's more specific for those <unk>.

Jen Moses: and other administrative costs. We ended the second quarter with cash and cash equivalents of $245,000.

Jen Moses: We have a cash equivalence of $244 million, and we expect our current financial position to be sufficient to fund operations into 2023.

<unk> of patients that will be started in the inpatient setting so that is a <unk>.

Very small percentage of cross sell of patients based upon our market research, but when you couple that with the C code and the J code.

Basically we've got the entire waterfront covered so.

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

That's what I would share on the.

It is helpful.

But it's really when you look at it.

And the totality, it's really just an extremely positive coverage and reimbursement environment.

John E. Bailey: Thank you, Jen, Raj, and Will. Now, before we close the call, I want to, as always, thank the people living with cancer for their inspiration. As we know, we're only a couple days past World Lung Cancer Day. I'd like to specifically acknowledge those families who have experienced the impact of lung cancer, past and present, and the important work that thoracic oncologists, oncology nurses, and their staff do to care for people living with it.

Alright, great. Thanks, very helpful and congrats again.

Thank you Jeff.

And your next question comes from the line of Joseph Thome from Cowen <unk> Company. Your line is open.

Good evening and thank you for taking my questions.

Maybe the first 1 it was indicated that some some areas seem to be outperforming and maybe others for our underperforming.

Okay.

Perfect.

Do you have any is it based on geography or maybe some price.

What are you seeing sort of supportive care agents or somewhere clinical trials site every day.

And for making me now would be helpful.

And then maybe on the T&D key.

John E. Bailey: We are well aware of the importance of the work we are doing at G1 for patients with lung cancer and that there is a great need for this first and only proactive multilineage myeloprotection treatment. Before we move to Q&A, let me just recap what you've heard today. The combined commercial team is heavily focused on executing the plan in the second quarter and took early steps forward to getting Coacella widely tried and adopted over the long term. We have no issues with reimbursement.

Obviously, we're expanding the development of fatality free was that upcoming study.

Will you, let me looking for kind of per Castello with other maybe accrued able flow space for like an ECB.

<unk> was approved last year.

The.

Reasonable.

Thanks.

Sure ill handle the first 1.

And then I'll flip it over to Raj in the second 1.

This is really it's more on the execution side.

Joe.

Certainly there is no geographic boundaries when it comes to small cell lung cancer. So it takes and this is really execution, we are aligned with our partner on that.

John E. Bailey: We continue to hold a majority of our sales calls virtually. We do expect that to change over time, however, as the U.S. continues to open up, but we will monitor the impact of COVID variants. In instances where our target organizations stay virtual, we will continue to adapt to ensure that we are reaching them as effectively as possible.

We know what the issues are.

Some of it requires training some of its more attention.

For the Bottomline is solvable and we are working for 2 making sure we saw that across the country in terms of the PBC study potential Boston that let me turn it to Raj, Yes, Hey, Joe Yeah. So that that MLA CNBC study, we are very excited about further define the mechanism.

John E. Bailey: We initiated three new trials in the second quarter, a phase three registrational trial in metastatic triple negative breast cancer, and two phase two trials in patients with non-small cell lung and bladder cancer. We also expect to initiate a new phase 2 trial late this year to further define the anti-tumor mechanism of action of Cocella. As a result, we expect to have numerous data readouts starting in the second half of next year. We recently received fast-track designation for Cosella in triple negative breast cancer, which is a regulatory pathway used to get important new drugs to the patient earlier by providing regulatory support and other benefits.

Theres a lot of data on the effect of <unk> on T. Regs in particular on CD 8 T. Reg ratio, so that would be our focus and we'll talk more about that.

As we near initiation of the study.

Regarding ADC, yes, we're definitely interested in exploring that study as well.

As for the class of drugs.

Clearly.

Becoming entrench into number of number of spaces, including CNBC.

Great. Thank you and congratulations.

Thank you.

And your next question comes from the line of Tom Shrader from BPI G. Your line is open.

Hi, good afternoon, congratulations not an easy time to launch a drug.

Yes.

A couple of questions on the clinical trials you announce.

John E. Bailey: And finally, our CASH Runway Guidance is unchanged from our last setup guidance, taking us into 2023. Thank you for your time this afternoon. We will speak again in this format on the November call, though I'm sure we'll see many of you before then during the late summer and fall slate of virtual healthcare conferences and non-deal roadshows. Hopefully, we can see many of you in person in due time as well. 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?

What is your sense about how many trials you're going to have to run on the few show myeloma preservation in second line third line non small cell lung cancer do you think you would get an approval for first line as well or is it just no way to know just your sense.

How many trials you have to do.

Yes.

It's a fair question, Tom we appreciate it and I think a lot of folks have.

Trying to figure this 1 out I don't think we have a great answer for you beyond we're going to we really have a tumor agnostic vision for cross sell up and so we're going to continue to execute on these studies to try and buildup that repository of.

Across an array of different regimens in tumor type so.

Whether or not at some point regulators.

Choose to give it a broader label, it's tough to predict what I would say is.

Operator: Thank you, sir. And as a reminder, to ask a question, please press the star and the number one key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Your first question comes from the line of Chad Messer from Needham & Co. Your line is open.

A lot of the payers in the compendium listings up Belle take a different perspective and begin to reimburse. So I think we have to separate the 2 sort of a formal regulatory label change. After so many studies versus getting reimbursement with the broader label. So, but we're going to continue to execute on these net again, we're encouraged with things like the Fas.

Track designation, where we can continue to engage with the regulatory bodies.

I will make sure we can get that we'll sell up brought to market for this broader indications.

Chad Messer: I say thanks, good evening, and congrats on a solid quarter, early on a lot of milestones being met. I'm wondering if you could...

Yes.

Second question on the <unk> trial, so youre, maintaining costello during the available value lab value maintenance only.

Chad Messer: Educate us a little bit, Ferg.

Chad Messer: Further on the importance of the NTAP decision that you reported this morning, if there was an actual amount that sort of a maximum reimbursement amount that was given, I [inaudible]

What's going on there is there enough casella to have efficacy as our CDK for six's active here are just a thought on extending that could certainly use.

Chad Messer: Granted, obviously, at this point...

Chad Messer: Obviously, at this point in launch, getting reimbursed is a pretty major factor in uptake.

Yes, Hey, Tom This is Raj.

So sorry, if I was not clear in my remarks.

The design is patients get up to 6 cycles that G. Objective platinum had then if the disease has not progressed they will receive a value Matt is maintenance so that as the control arm, we're going to get casella with gemcitabine platinum as well as a value Bob.

John E. Bailey: Yeah, thanks, Chad. I appreciate the questions. You know, when you look at both the NTAP, the C-code, and the J-code, I mean, it all speaks to, frankly, what we would view as a very positive reimbursement environment. All of those, of course, are via CMS. We also have the commercial market, where, as we mentioned, every payer is allowing claims for Coacella to flow through according to label, and several have written formal policies. So I think it all speaks to your point. What is normally one of the biggest concerns early in a product launch is coverage and reimbursement. We feel very, very good.

So it's throughout the duration of treatment.

In terms of Casella.

Theres actually.

We have data pre clinically and all of our mechanism of action data suggest that.

Debt, there's a good rationale for combining it with with a checkpoint inhibitor of both alone as well as in combination with chemo had checkpoints. So that's the rationale for the design.

Alright, great. Thanks.

And your next question comes from the line of David Ian Gordon from Wedbush Securities. Your line is open.

Hey, Thanks for taking the questions maybe if.

John E. Bailey: My personal experience says this is as good as I've seen it in probably a decade or a decade and a half for a new product, whether it's commercial or Medicare patients. Now, in terms of the NTAP itself, it's more specific for those minority of patients that will be started in the inpatient setting. So that is a very small percentage of Coacella patients based on our market research. But when you couple that with the C-code and then the J-code, basically, you've got the entire waterfront covered. That's what I would share about the intent. It's helpful, but when you look at it in the totality, it's really just an extremely positive coverage and reimbursement environment.

If I could a little bit more detail on the tap.

<unk> payment.

Specifically.

Where does that place you relative.

Are you on the physicians reimbursement relative to other.

Yes.

Neulasta is or other whitesell support agents.

And then a second question on the bladder cancer study are there.

I mean, obviously youll be watching for myeloma suppression in there is there a plan or a scenario, where if you don't necessarily see stat Sig benefit on progression free survival is there a mechanism to maybe expand the study or 2.

Chad Messer: All right. Great. Thanks. Very helpful.

Operator: And your next question comes from the line of Joseph Thome from Cohen and Company. Your line is open.

Looking at my old preservation endpoint to Tom's point.

Yes.

Accelerate the process of getting a broader approval in multiple tumor types for at least myeloid preservation. Thanks.

Joseph John: Good evening, and thank you for joining us.

Joseph John: Thank you for taking our questions. Maybe the first one: it was indicated that some areas seem to be...

Joseph John: to be outperforming, and maybe others are underperforming.

Yes, I'll take the first 1 on the impact and then I'll, let Roger speak a little bit more on the bladder yes on the untapped for me first of all if you look at the economics, especially for the inpatient setting where again the impact is more applicable whether you look from a net cost recovery for from an administration fee. The economics are very favorable for cross sell up.

Joseph John: Um, are there any specific reasons why that might be happening? Is it based on geography?

Operator: https://www.kenhub.com

Joseph John: And then maybe on to TNDC; obviously, we're expanding the development of telecare with that.

For the untapped really avoids and the whole intent of it when it started years ago was to not penalize. The net DRG setting orders 1 set payment and new innovation comes in in the health care system may avoid using it EBIT. If it's got the potential to improve patient outcomes et cetera. So from our standpoint I would say.

Joseph John: [inaudible]

John E. Bailey: Sure, I'll handle the first one, and then I'll flip it over to Raj on the second one. You know, this is really, it's more on the execution side, Joe. It, you know, certainly there are no geographic boundaries when it comes to small cell lung cancer. So at Dave's end, this is really, it's execution. We're aligned with our partner on that. We know what the issues are. Some of it requires training. Some of it just needs more attention.

It just continues to have.

Provide casella with favorable economic net inpatient setting, but again I would just go back to the broader issuance coverage and reimbursement is really the key takeaway. We've got frankly, a really optimal scenario here, whether it's for those Medicare patients or for those commercial patients so but in turn.

For bladder will need have Raj speak for that yes, Hey, David Yes. So this is mark to 2 comments I would make the first debt. This is an open label study.

John E. Bailey: But the bottom line is it is solvable, and we are working forward to making sure we solve that across the country. In terms of the TMBC study, potential thoughts on that, let me turn that to Raj.

So obviously with it.

We'll be looking at the data and if there is a strong model signal I think that is certainly a possibility.

John E. Bailey: Yeah, hey Joe, yeah, so that MOA...

Second is that.

Rajesh K. Malik: It's a great TMBC study we're very excited about.

Our experience to date, but there is a model of signal it's apparent in relatively small numbers of patients. This is 90 patients 45 per arm. So the size of the study could be sufficient to actually pick that up as well.

Rajesh K. Malik: There's a lot of data on the effect of Casella on Tregs, in particular, and CDH.

Rajesh K. Malik: to Treg Ratio, so that would be our focus, and we'll talk more about that.

Rajesh K. Malik: about that as we near the initiation of the study. Regarding ADC, yes, we're

Yes.

That would be part of that was what is the.

Background rate on myeloid suppression and bladder patient so I assume it's sufficient to see a delta then as you mentioned in a in a short order or with fewer patients.

Rajesh K. Malik: We're definitely interested in exploring that study as well since this is a class of drug.

Rajesh K. Malik: and a class of drugs that's...

Rajesh K. Malik: Clearly, you know, becoming entrenched in a number of number of spaces, including TMT.

Yes. So this is really both includes both gemcitabine and cisplatin and cardio the assist as the preferred but insists on an eligible we'd get cargo and they're both.

Joseph John: Great. Thank you, and congratulations.

Operator: And your next question comes from the line of Tom Schrader from BTIG. Your line is open.

Tom Schrader: Good afternoon. Congratulations. Not an easy time to launch a drug. I had a couple of questions about the clinical trial.

Obviously myeloma process. So, yes, I think thats, a reasonable number of patients too.

Yes.

Get a get a read on that.

Tom Schrader: on the clinical trials you announced.

Got it thank you.

Thank you David.

Once again, if you would like to ask a question for Todd and the number 1 key our net Touchstone telesales for your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

Tom Schrader: What is your sense about how many trials you're going to have to run? If you show myelopreservation in second line, third line, non-small cell lung cancer, do you think you would get an approval for first line as well? Or is there just no way to know? Just your sense. How many trials do you have to do?

And your next question comes from the line of Tony Butler from Roth Capital. Your line is open.

Yes, thanks very much just just.

John E. Bailey: Yeah, it's a fair question, Tom, we appreciate it, and I think a lot of folks have tried to figure this one out. I don't think we have a great answer for you beyond that we really have a tumor-agnostic vision for Cocella, and so we're going to continue to execute on these studies to try and build up that repository of proof across an array of different regimens and tumor types. So, you know, whether or not at some point regulators will choose to give it a broader label is tough to predict.

Really 2 questions in there on the.

Clinical trials, which are enrolling and ongoing.

I noticed rossing clinical trials to other work that preserve 3 in bladder cancer.

Currently has only 1 site enrolling patients and I wondered if you could speak to that.

And then also with respect to.

Yeah.

Preserved for.

And then the CLC there or for sites. It seems that theres, a tremendous amount of activity going on certainly in preserve 1 preserve too so I just wanted to.

John E. Bailey: What I would say is, you know, a lot of the payers in the compendia listings will take a different perspective and begin to reimburse, so I think we have to separate the two, sort of a formal regulatory label change after so many studies versus getting reimbursement with a broader label. So, we're going to continue to execute on these, and again, we're encouraged by things like the Fast-Track designation where we can continue to engage with the regulatory bodies that will make sure we can get Cocella brought to market for these broader indications. Great, and a second question on the urothelial trial. So you're maintaining Costella during the...

And I realize for new and I know having for trials ongoing can be cumbersome for a small company.

But I appreciate your thoughts on on the site.

Thank you.

Yeah, Hey, Tony So yes, we are.

Both studies for 1 initiated in May the other 1 in June so we're very much in the site activation.

Part of the study and the other the other point actually as there are more sites that are currently visible on Central's dot Gov. It always takes a couple of days for them to be updated and that's a continuous process.

So yes, but the patients are being enrolled we've enrolled patients other non small cell lung cancer study.

And we expect the same to happen in bladder soon.

I appreciate your comments sure. Thank you Tony.

Tom Schrader: Evelia Lab, Evelia Lab Maintenance Only

Sure.

Tom Schrader: What's going on there? Is there enough Cocella to have efficacy? Are CDK4-6s active here? Just a thought on extending Cocella.

Im showing no further question at this time I would now like to turn the conference back to Mr. Johnson. Please go ahead Sir.

Thank you operator.

We are actively bringing <unk> to patients with extensive stage small cell lung cancer and conducting these intelligently designed clinical trials to maximize the future value of applicability of this unique drug in a variety of cancers.

Rajesh K. Malik: Yeah, hey Tom, this is Raj.

Rajesh K. Malik: Sorry if that was not clear in my remarks; the design is patients get up to six cycles of GFG, and then if the disease does not progress, they will receive a value map as maintenance.

As always I look forward to keeping you updated as we move forward. Thank you for joining us today and good afternoon.

Rajesh K. Malik: So that is the control arm. We're going to get Cosella with gemstidabine platinum as well as

And this concludes today's conference call. Thank you all for your participation and have a wonderful day.

Rajesh K. Malik: as well as value-add maintenance. Um, so it's throughout the duration.

Mark.

Okay.

[music].

Rajesh K. Malik: There's actually, you know, we have data pre-clinical, and all of our mechanism of action data suggests that, you know, there's a good rationale for combining it with a checkpoint inhibitor.

Yes.

Sure.

Yes.

[music].

Rajesh K. Malik: with a checkpoint inhibitor, both alone as well as in combination with chemo and checkpoints. So that's the rationale for the treatment.

Sure.

[music].

<unk>.

[music].

Sure.

[music].

Yes.

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[music].

Operator: And your next question comes from the line of David Nierengarten from Redbush Securities. Your line is open.

David Matthew Nierengarten: Thanks for taking the questions. Maybe, if I could, a little bit more detail on the NTAP payment. Specifically, where does that place you relative to physician reimbursement relative to other new LASTAs or other white tail support agents? And then a second question on the bladder cancer study. Obviously, you'll be watching for myelosuppression in there. Is there a plan or scenario where, if you don't necessarily see stats that benefit progression-free survival, is there a mechanism to maybe expand the study or to look at a myelopreservation endpoint? To Tom's point, you'll accelerate the process of getting broader approval in multiple tumor types for at least myelopreservation. Thanks. Yeah, I'll take the first one.

Alright.

Yeah.

[music].

John E. Bailey: Yeah, I'll take the first one on the NTAP, and then I'll have Raj speak a little bit more on the bladder. Yeah, on the NTAP, I mean, first of all, if you look at the economics, especially for the inpatient setting, where the NTAP is more applicable, whether you look at it from a net cost recovery perspective or from an administration fee, the economics are very favorable for Cocella. The NTAP really avoids, and the whole intent of it when it started years ago, was to not penalize providers in that DRG setting where there's one set payment, and new innovation comes in, and the healthcare system may avoid using it, even if it's got the potential to improve patient outcomes, et cetera.

John E. Bailey: So from our standpoint, I would say it just continues to provide Cocella with favorable economics in that inpatient setting. But again, I would just go back to the broader issue of coverage and reimbursement. We've got, frankly, a really optimal scenario here, whether it's for those Medicare patients or for those commercial patients.

John E. Bailey: David, there are two comments I'd make. The first is that this is an open-label study, so obviously, we would be looking at the data, and if there is a strong viral signal, I think that is certainly good.

Rajesh K. Malik: I would be looking at the data, and if there is a strong myelosignal, I think that is certainly a possibility. The second is that, in our experience to date, when there is a myelosignal, it's apparent in relatively small numbers of patients.

Rajesh K. Malik: Yeah, I mean, part of that was, you know, what is the kind of background rate for myelosuppression in bladder patients? So, I assume it's sufficient to see a delta then, as you mentioned, in a short order or with fewer patients.

Rajesh K. Malik: Yeah, so this is really both; it includes both gemcitabine, cisplatin, and carbo, so cis is preferred, but in cis-anodyne.

Rajesh K. Malik: Platin and Carvo, so cysts are preferred, but in cysts and ineligible, we get Carvo, and they're both, you know, both obviously myelosuppressive, so yeah, I think it's a reasonable number of patients to get a read on that.

Operator: Once again, if you would like to ask a question, press start and the number 1 key on your touchtone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. And your next question comes from the line of Tony Butler from Ross Capital. Your line is open. Yes, thanks very much.

Tony Butler: Yes, thanks very much. Just really two questions, and they're about the Clinical Trials, which are enrolling and ongoing. I noticed, Raj, on clinicaltrials.org that Preserve 3 and bladder cancer currently have only one side enrolling patients. And I wondered if you would speak to that. And then also with respect to... preserve 4 in NSCLC. There are four sites. It seems that there's a tremendous amount of activity going on, certainly in Preserve 1 and Preserve 2, so I just wanted to,

Tony Butler: Yeah, hey, Tony. So, yeah.

Rajesh K. Malik: Both studies, so one initiated in May, the other one in June, so we're very much in the site activation part of the study. And the other point is that there are more sites than are currently visible on clintrials.gov. It always takes a couple of days for them to be updated, and that's a continuous process. So yeah, but patients are being enrolled. We've enrolled patients in the NOSMOS Lung Cancer Study, and we expect the same to happen in bladder cancer soon.

Operator: I'm showing no further questions at this time. I would now like to turn the conference back to Mr. Jack Bailey. Please go ahead, sir.

John E. Bailey: We are actively recruiting co-cellulative patients with extensive stage small cell lung cancer and conducting these intelligently designed clinical trials to maximize the future value and applicability of this unique drug in a variety of cancers. As always, I look forward to keeping you updated as we move forward. Thank you for joining us today. Have a good afternoon, and this guy.

Operator: And this concludes today's conference call. Thank you all for your participation and have a wonderful day. You may all disconnect.

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Operator: Good day, thank you for standing by, and welcome to the G1 Therapeutics 2nd Quarter 2021 Financial Results conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow at that time. If anyone should require assistance during the conference, please press star then zero on your touchtone telephone. I would now like to turn the conference over to your host, Mr. Will Roberts. Please go ahead, sir.

[music].

Operator: Thank you, lads. Good afternoon, everyone, and welcome to the G1 conference call to discuss our second...

Operator: and discuss our second quarter 2021 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 the news section.

Operator: and in the news section of our corporate website, g1therapeutics.com.

Operator: On this call, the team will provide a business overview for the second quarter of 2021, including an update on our launch progress in that period with Costella, which was approved by the U.S. Food and Drug Administration on February 12, 2021, to decrease the incidence of chemotherapy-induced myeloid suppression in adult patients when administered prior to a platinum methoxide-containing regimen or to a fatigue-containing regimen for extensive-stage small cell lung cancer or A question and answer session will follow the prepared remarks. Before we begin, I want to remind you that today's webcast contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.

Operator: and may involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements. For more information on such risks and uncertainties... Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website. Any forward-looking statements represent our views as of today, August 4, 2021. Joining me on the call today is Jack Bailey, our Chief Executive Officer...

Operator: Jen Moses, our Chief Financial Officer, and Raj Malik, our Chief Medical Officer.

Operator: With that, I'll turn the call over to Jack. Okay?

John E. Bailey: Thanks Will. Good afternoon everyone, and thank you for joining us on the call today. Today's headline from the second quarter is one of a continued focus on execution, both as it relates to our early readout of our ongoing commercial launch of Costella and as it relates to our clinical program. Now I joined G1 because of our shared commitment to improve the lives of people impacted by cancer. This core mission is tangible at G1, and I am confident in the G1 team as we seek to help as many people with cancer as we can and drive long-term value for our shareholders.

John E. Bailey: We believe Cocella is a paradigm-changing drug. It is the first and only multilineage myeloprotection therapy to offer proactive protection against the dangerous impacts of myelosuppression when treating small cell lung cancer patients with certain chemotherapy regimens. It allows oncologists treating small cell lung cancer patients to move away from treating significant myelosuppressive side effects individually with different drugs after the damage has been done and, instead, enabling them to help decrease or prevent the occurrence of these side effects altogether with the proactive use of a single therapist.

[music].

John E. Bailey: And during the second quarter, we continued to lay the groundwork for broad commercial access to Costella as we made progress toward our long-term goal of ensuring the availability of this important drug. But we also remain equally focused on Cosella's next indication. During the second quarter, we initiated three new clinical trials with Cocella, including a registrational trial in metastatic triple-negative breast cancer and two Phase II trials in patients with non-small cell lung and bladder cancer.

John E. Bailey: This is in addition to the pivotal trial in colorectal cancer dosing, which was initiated in the first quarter. So in total, we now have two phase three registrational trials and three phase two trials ongoing with multiple readouts starting in the second half of 2022. Now, we have a lot of important content to cover today.

John E. Bailey: We appreciate her contributions to the planning and the launch of Cosella and certainly wish her the best going forward. We also announce at the same time that we have hired a new Chief Commercial Officer. Andrew Perry is the former Vice President, U.S. Marketing at Deep Healthcare North America, a joint venture majority owned by GlaxoSmithKline. He is a proven leader and strategist with a history of driving consistent performance and commercial success, and has tremendous commercial experience across a wide variety of specialties, including oncology, especially in areas including commercial launch strategy, execution, and co-promotion management. Andrew starts on August 16th, and I really look forward to having all of you meet him at our next business update.

Good day, Thank you for standing by and welcome to the G..1 therapeutic second quarter 2021 financial results conference call.

At this time all participants are in a listen only mode. Later, we will conduct a question and answer session and instructions will follow at that time.

John E. Bailey: Now turning our attention first to the commercial update, the launch efforts of the combined G1 and Beringer-Egelheim commercial team during the quarter resulted in us booking $2.5 million in net sales of Coastella for the quarter ending June 30th. Much of the last three months has been spent with various community practices and hospital systems to gain inclusion on formulary and order sets, and this will remain a key focus for the coming months as well.

If anyone should require assistance during the conference. Please press Star then zero on your Touchtone telephone I would now like to turn the conference over to your host Mr. Weil Roberts. Please go ahead Sir.

Thank you Bob.

Afternoon, everyone and welcome to the G..1 conference call to discuss our second quarter 2021 financial results and business update.

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

On this call the team will provide a business overview of the second quarter of 2021.

Clothing and update on our launch progress in that period with Castilla.

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 a flattening on the filter side, considering the edge net or Chuck for chicken containing regimen for extensive stage small cell lung cancer or SCLC and became available.

In the channel in early March of 2021.

A question and answer session will follow the prepared remarks.

Before we begin I want to remind you that today's webcast contains forward looking statements within the meaning of the private Securities Litigation Reform Act of 1995.

Such statements represent managements judgment as of today.

They involve risks and uncertainties that could cause actual results to differ materially from those expressed in or implied by these statements.

For more information on such risks and uncertainties. Please refer to our filings with the Securities and Exchange Commission, which are available from the SEC or on our corporate website.

Any forward looking statements represent our views as of today August for 2021.

John E. Bailey: As of the end of June, our unaided awareness, or awareness of Cocella without specific prompts, was at 56%, and Aided Awareness based upon questions on familiarity with CoCell and its indication was at 77%. These are both above benchmark for this point in an oncology product launch. Now regarding coverage and reimbursement, all of the payers have been covering Coacella when written to label. Approximately 60% is Medicare Part B, 30% is commercial, and the remaining 10% is government and other forms of coverage.

Joining me on the call today are Jeff Bailey, our Chief Executive Officer, Jen Moses, our Chief Financial Officer.

And I'll, let our chief Medical officer with.

With that I'll turn the call over to Jeff Jeff.

Good afternoon, everyone and thank you for joining us on the call today.

Today's headline from the second quarter is 1 of a continued focus on execution both as it relates to our early readout of our ongoing commercial launch of <unk> and as it relates to our clinical programs.

Joining Q1 because of our share commitment to improve the lives of people impacted by GM Sir.

This core mission is tangible at G..1 and I am confident in the <unk> as we seek to help as many people with cancer as we can and drive long term value for our shareholders.

We believe Costar is a paradigm changing drug it.

It is the first and only multi lineage Milo protection therapy to offer proactive protection against the fee interest impact of viral suppression when treating small cell lung cancer patients with certain chemotherapy regimens.

John E. Bailey: We've had formulary approval at 18 of our top 100 organizations, and 21 organizations have proceeded with the inclusion of Costella into their order set. However, not all of our top 100 organizations have a P&T process for use, and some are still determining how to incorporate Cocella into their order set. We expect additional approvals over the coming months. Now, as you may recall, we filed for our C-code and permanent J-code in March, and we recently received both.

It allows oncologists treating small cell lung cancer patients to move away from treating significant mark most impressive side effects individually with different drugs. After the damage has been done to instead, enabling them to help decrease while prevents the occurrence of these side effects altogether with debt.

Proactive use of a single therapy.

And during the second quarter, we continued to lay the groundwork for broad commercial access to cross sell as we made progress toward our long term goal of ensuring the availability of this important drug.

John E. Bailey: Our C-code for pass-through hospital outpatient system use became effective on July 1, and our permanent J-code for all sites of care across all channels will become effective on October 1. And as you saw this morning, we were just issued a new technology add-on payment, or NTAP, for Costella. It will also become effective for provider billing on October 1st, 2021.

Bladder cancer.

This is in addition to the pivotal trial in colorectal cancer dosing for which was initiated in the first quarter. So in total we now have 2 phase III Registrational trials and 3 phase II trials ongoing with multiple readouts starting in the second half of 2022.

John E. Bailey: The NTAP is an important tool that provides additional payment to hospitals above the standard DRG payment. Moving on to engagement, as of the end of June, the team achieved approximately 53% reach to our 2,500 targeted HCPs and made an additional nearly 4,000 targeted calls to other prescription-enabling functions, such as nurses and pharmacists, who are critical stakeholders in the supportive care space. At the end of Q2, almost 60% of these calls were still virtual.

Thank you.

And we have a lot of important content to cover today I will cover our commercial efforts for the second quarter of 2021, the first full quarter of cross sell out sales and also provide an update on our leading and lagging indicators of cross sell on access and uptake that we introduced on the last call Raj will then provide an update.

Some of our medical efforts and clinical milestones during the second quarter.

He will also touch on the upcoming trial that we expect to initiate in the fourth quarter of this year designed to further define the immune based anti tumor mechanism of action of cross sell for.

John E. Bailey: And while we believe the ratio of in-person to virtual calls will improve over time, we don't yet know how quickly or how many institutions will remain virtual in a post-COVID environment. As some of our oncology peer companies have recently stated, the oncology category is lagging most other therapeutic areas, many of which were approaching pre-COVID levels. This is a macro issue which we are closely monitoring as we head into the next few months.

Finally, Jim will provide the financial results for the quarter, then I'll be back for some concluding comments.

Now before we discuss our results for the quarter you likely saw that on Monday, we announced that Soma Gupta left the organization for personal and professional reasons.

We appreciate her contributions to the planning and the launch of <unk> and certainly wish you the best going forward.

We also announced at the same time that we have hired a new chief commercial officer, Andrew Perry, The former Vice President U S marketing, a deep health care North America joint venture majority owned by Glaxosmithkline.

John E. Bailey: This also underscores that continued maturation of our virtual capabilities will continue to be vital, as this will be an increasingly important and expected way to reach many in our target audience. From a utilization perspective, in the second quarter, 70% of our demand came from community hospitals or clinics, with the remaining 30% coming from academic hospitals. Additionally, they received orders from 68 unique organizations, up from 20 at the end of March.

Steve and I really look forward to having all of you.

And our next business update.

Now turning our attention first to the commercial update the launch efforts of the combined G..1 and barrier Eagle on commercial team during the quarter resulted in us booking $2.5 million and net sales of co sell up for the quarter ending June 30 day.

John E. Bailey: 28 of those are from our top 100 priority organizations, again, up from 7 that had ordered at the end of March. These priority organizations are essential to not only driving the breath or trial of Costella into community and hospital accounts across the U.S. but also the depth or number of physicians in any given practice using a drug and encouraging others to do so. At this point, the breadth of adoption to date of Cocella is directionally correct.

Much of the last 3 months was spent with various community practices and hospital systems to get any inclusion on formulary in order sets and this will remain a key focus for the coming months as well.

For those not familiar with the process of formulary inclusion.

It's multi step requiring doctor advocacy and a practice or institution, having a successful PMG scheduled and decision taken.

And then where they exist incorporation into EHR order sets.

It's worth noting net this year, primarily due to the slow open other country. We have seen a number of these planned for <unk>.

John E. Bailey: However, we are increasing our efforts to drive depth across these areas. Now, before I close, I want to comment on some things we are seeing in the channel for the third quarter. We have seen some recent softness in orders, which we believe is addressable.

Greetings postponed which can affect the speed of uptake.

On our last call, we set up a variety of leading and lagging indicators to help you follow our progress quarter over quarter, which I will now cover.

I'll focus on our 4 key areas awareness coverage and reimbursement engagement and utilization.

John E. Bailey: As you've just heard, the performance metrics for the second quarter are solid, despite a slower-than-ideal opening of the country. We have good awareness. The product is performing clinically as expected, and physician experience with the drug is excellent. And we have encouraging data that shows accounts that trial the drug are embracing it, so strong depth can be achieved. Our breath, as I said, is directionally correct, but driving depth is the next challenge. We have some regions of the country that are outperforming on this dimension; others are underperforming.

Now for awareness, both aided and unaided are solid.

As of the end of June our unaided awareness or awareness of casella without specific prompts was at 56%.

And aided awareness based upon questions on familiarity with co sell into syndication was at 77%. These are both above benchmark for this point in an oncology product launch.

Ah regarding coverage and reimbursement.

All of the payers have been covering co sell with written to label.

Approximately 60% is Medicare part B, 30% is commercial and the remaining 10% is government and other forms of coverage.

John E. Bailey: We will look to address this and drive more consistent and stronger execution across the country in all regions. So to summarize, our net sales for the second quarter were just over $2.5 million, and both aided and unaided awareness are up, which is baseline for a product like this. We have moved through several operational hurdles, for example, the NCCN guidelines and payer reviews, while still having many T&T processes yet to complete. We have seen no issues with coverage and reimbursement, and we have received our C-code, permanent J-code, and NTAP, with the latter two being effective on October 1st of this year.

And we now have payer policies in place or pending that provides coverage for approximately 80% of on label patient lives.

3 of the top 5 U S payers have made positive flow coverage decisions within the first 4 months of product availability.

Most importantly, we are not seeing any pushback in terms of reimbursement of filed claims.

We have had formulary approvals at 18 of our top 100 organizations in 'twenty..1 organizations have proceeded with inclusion of cross sell into that order sales now.

Now not all of our top 100 organizations have a process for us and some are still determining how to incorporate <unk> into their order sent we expect additional approvals over the coming months.

John E. Bailey: We will continue to monitor the impact of COVID-19 variants on the opening of our target community practices and hospital systems and their willingness to receive reps into their offices. And while in-person selling is important, and also likely more critical for a buy-and-bill sale like Cosella, we intend to remain as effective as possible, even in a virtual sales environment, and will continue to evolve and improve our virtual capabilities going forward. Now, with that, I'll turn it over to Raj for an update on our medical and clinical efforts during the second quarter. Raj?

And as you saw this morning, we were just issued a new technology add on payment and cash for cross seller. It will also become effective for provider billing on October 1.2021.

The <unk> is an important tool that provides additional payment for hospitals above the standard DRG payment model.

Moving on to an engagement perspective as of the end of June the team has achieved approximately 53% reach to our 2500 targeted hcp's and made an additional nearly for targeted calls to other prescription enabling functions such as nurses and pharmacists.

Rajesh K. Malik: Thanks, Jack, and good afternoon, everyone. I'm going to cover three topics. First, I will provide a brief update on a few of our medical affairs efforts during the quarter. I'll then provide an overview of the two Phase II trials we initiated in the second quarter. And I'll introduce a new trial that we intend to initiate before the end of this year, designed to further define the mechanism of action of Cosella. It's a small study, but one that we expect to generate a tremendous amount of important data.

Mark critical stakeholders in the supportive care space.

At the end of Q2, almost 60% of these calls we're still virtual.

And while we believe the ratio of in person to virtual calls will improve over time, we don't yet know how quickly for how many institutions will remain virtual in a post COVID-19 environment.

As some of our oncology peer companies have recently stated the oncology category is lagging most other therapeutic areas many of which were approaching pre COVID-19 levels.

Rajesh K. Malik: From a medical affairs perspective, we continue to implement our...

This is a macro issue issue, which we are closely monitoring as we head into the next few months.

Rajesh K. Malik: Our medical communications plan during the second quarter, which includes ensuring broad visibility of our data among the medical community and identifying avenues for scientific dialogue. For example, during the quarter, we presented data and had a presence at virtual and live meetings, including the International Society for Pharmacoeconomics and Outcomes Research, or ISPOR, meeting and ASK. At ISPOR, we presented two posters describing the estimated economic impact of treating myelosuppression among patients with extensive stage small cell lung cancer.

This also underscores the continued maturation of our virtual capabilities will continue to be vital as this will be an increasingly important and expected way to reach many in our target audience.

From a utilization perspective in the second quarter, 70% of our demand came from community hospitals or clinics with remaining 30% coming from academic hospitals.

We received orders from 68 unique organizations up from 20 at the end of March.

<unk> 28 of those are from our top 100 priority organizations again up from 7 debt at the end of March.

Rajesh K. Malik: Of particular interest during the meeting was our poster that provided a cost-benefit model estimating the economic value of using Cocella prior to chemotherapy in extensive stage small cell lung cancer.

At this point the breadth of adoption to date of course outlet is directionally correct. However, we are increasing our efforts to drive GAAP across these accounts.

Rajesh K. Malik: From a U.S. commercial payer perspective, the projected estimated total cost savings per patient is approximately $15,000 based on a projected reduction in myelosuppressive adverse events and their associated treatment costs with on-label treatment.

Now before I close I want to comment on some things we are seeing in the channel in the third quarter.

We have seen some recent softness in orders, which we believe is addressable.

Rajesh K. Malik: Overall, the model indicates that Cocella is an economically favorable innovation when addressing the incidence of model suppression in patients with extensive stage small cell lung cancer. We were also very active at ASCO, presenting posters, interacting with key opinion leaders in oncology via our virtual booth, and sponsoring a peer-reviewed CME program called Long-Awaited Treatment Advances Give Cause for Optimism.

Just turn to performance metrics for the second quarter, our solid despite a slower than ideal opening of the country. We have good awareness the product is performing clinically as expected.

<unk> experience with the drug is excellent and we have encouraging data that shows accounts that trial. The drug are embracing it so strong debt can be achieved.

Our breath as I said is directionally correct, but driving depth is the next challenge we have some regions of the country that are outperforming on this dimension however, others.

Rajesh K. Malik: Finally, as I mentioned on the last call, since the approval of Cosella, we've had marked interest in our scientific platform and real-world evidence generation. We've been pleased with the interest in our investigator-initiated study program.

Our underperforming we will look to address this and drive more consistent and stronger execution across the country in all regions.

So to summarize our net sales for the second quarter were just over $2.5 million.

<unk> aided and unaided awareness are up baseline for a product like this we have moved through several operational hurdles. For example, the <unk> guidelines and payer reviews, while still having many pnp processes yet to complete.

Rajesh K. Malik: and Some of these studies will start later this year.

Rajesh K. Malik: Additionally, we are working with oncology centers so that they can assess the burden of chemotherapy-induced malusuppression in their own practice.

Rajesh K. Malik: Switching now to clinical...

We have seen no issues in coverage and reimbursement and we have received our C code permanent J code and then tap with the latter 2 being effective on October 1 of this year.

Rajesh K. Malik: [inaudible] Our colorectal trial is ongoing, and we initiated three new trials during the second quarter. We discussed the Phase III triple-negative breast cancer trial on our last call, so I'll discuss the two Phase IIs today. In May, we initiated PRESERVE-4, a multicenter, randomized, double-blind, placebo-controlled phase 2 study of Costella administered prior to docetaxel in approximately 146 patients with metastatic non-small cell lung cancer in the second and

We will continue to monitor the impact of COVID-19 variance on the opening of our target community practices and hospital systems and their willingness to receive reps into their offices.

While in person selling is important and also likely more critical for a volume bill sell like for seller, we intend to remain as effective as possible even in a virtual sales environment.

We will continue to evolve and improve our virtual capabilities going forward.

Now with that I'll turn it over to Raj for an update on our medical and clinical efforts during the second quarter Raj.

Rajesh K. Malik: second and third line.

Thanks, Jack and good afternoon, everyone I am going to cover 3 topics first I will provide a brief update on a few of our medical affairs efforts during the quarter.

Rajesh K. Malik: who have previously been treated with a checkpoint inhibitor and chemotherapy. Non-small cell lung cancer is the most common type of lung cancer, accounting for 84% of the nearly 240,000 lung cancer diagnoses in the United States. For people diagnosed with metastatic disease, the five-year survival rate is only 7%. And unfortunately, despite improvements in therapy for metastatic non-small-cell lung cancer, including the use of PD-1 or PD-L1 inhibitors, the majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy. The primary endpoint of the trial is to evaluate the effect.

Ill then provide an overview of the 2 phase III trials, we initiated in the second quarter.

And I'll introduce a new trial that we intend to initiate for the end of this year.

Assigned designed to further define the mechanism of action of Casella.

It's a small study along debt, we expect to generate a tremendous amount of them for the data.

For example, during the quarter, we presented data and had a presence at virtual or live meetings, including the International Society for pharmacy, economics, and outcomes research or <unk> meeting at <unk>.

Rajesh K. Malik: effect of Cocella on overall survival compared to placebo

Rajesh K. Malik: Secondary endpoints will evaluate anti-tumor activity.

And as for we presented 2 posters, describing the estimated economic impact of trading model suppression among patients with extensive stage small cell lung cancer.

Rajesh K. Malik: and the multi-lineage myeloprotection benefit of Cosella compared to placebo, as in our other trials and will also...

Rajesh K. Malik: and we'll also assess faith. We expect to see interim data in the first half of 2020. Next, in June, we initiated PRESERVE-3, a Phase II randomized open-label study of Cosella administered with first-line platinum-based chemotherapy and the immune checkpoint inhibitor Velumab as maintenance therapy in approximately 90 patients with untreated locally advanced or metastatic urethelial or bladder carcinoma. There are approximately 84,000 new cases of bladder cancer every year, and unfortunately, the overall five-year survival rate for metastatic bladder cancer is under Patients are being randomly assigned one-to-one to one of two treatment arms.

Of particular interest during the meeting was a poster that provided a cost benefit model estimating the economic value of using cross sell up prior to chemotherapy in extensive stage small cell lung cancer from a U S commercial air perspective.

The projected estimated total cost savings.

Patient is approximately $15000.

On a projected reduction in mila suppressive adverse events and their associated treatment costs with on label use.

Overall, our model indicates that a seller is an economically favorable innovation, while addressing the incidents of modest pressure in patients with extensive stage small cell lung cancer.

We were also very active at <unk>, presenting posters interact interacting with key opinion leaders in oncology via our virtual booth and sponsoring a peer view CMV program called long awaited treatment advances have cause for optimism in small cell lung cancer.

Rajesh K. Malik: In one arm, they will receive Gemcitabine Platinum chemotherapy for...

Rajesh K. Malik: followed by a Value Map Maintenance Therapist. And on the other arm, they will receive Cosella.

Sure.

Finally, as I mentioned on the last call since the approval of Casella, We've had marked interest in our scientific platform and real world evidence generation.

Rajesh K. Malik: prior to chemotherapy, followed by Costella plus Valumab maintenance therapy.

Rajesh K. Malik: The primary endpoint is to evaluate progression-free survival during the overall study.

We've been pleased and the interest in our investigator initiated study program and some of these studies will start later this year.

Rajesh K. Malik: Key secondary endpoints will evaluate other measures of anti-tumor efficacy. We will also evaluate the Monkey Lineage Myeloprotective Effects of Collagen.

Additionally, we are working with oncology centers, so that they can assess the burden of chemotherapy induced model suppression in their own practice.

Switching now to clinical trial progress.

Rajesh K. Malik: Effects of Costella on Chemotherapy-Induced Myelosuppression and Safety. We expect to see data in the second half of 2022.

Colorectal trial is ongoing and we initiated 3 new trials during the second quarter we.

We discussed the phase III triple negative breast cancer trial on our last call. So I'll discuss the 2 phase twos today.

Rajesh K. Malik: Finally, as we develop Cocella in the clinic, we must continually ensure that we conduct

Rajesh K. Malik: These are all trials that we believe will maximize the value of Cosella. I'm happy to announce an upcoming Phase 2 trial that we believe will help to do exactly that. The trial is designed to evaluate the immune-based anti-tumor mechanism of action of Costella by assessing changes in the tumor microenvironment after administration of Costella. In this clinical study, in patients with...

Previously been treated with a checkpoint inhibitor and chemotherapy.

Non small cell lung cancer is the most common type of lung cancer accounting for 84% after nearly 240000 non.

Rajesh K. Malik: Patients with early stage triple negative breast cancer

Non cash of diagnosis in the United States.

For people diagnosed with metastatic disease.

Rajesh K. Malik: We'll be looking at changes in the ratio of CD8 T-cells to T-regulatory cells in the tumor microenvironment, along with a variety of other assessments of immune function following treatment with Cocella to further define what we believe is a broadly applicable mechanism of action. We expect to announce the initiation of this trial later this year, and we will provide more detail on the trial design at that time. Before I conclude, I'll briefly comment on our recent Fast-Track designation for Casella in combination with chemotherapy for triple negative breast cancer.

5 year survival rate is only 7%.

And unfortunately, despite improvements on therapy for metastatic non small cell lung cancer, including the use of PD, 1 or PDL 1 inhibitors. The majority of patients ultimately progress during or after treatment with immunotherapy and chemotherapy.

The primary endpoint of the trial is to evaluate the effect of casella on overall survival compared to placebo.

Secondary endpoints will evaluate antitumor efficacy and the multi lineage malware protection benefit of casella compared to placebo has at our other trials and we'll also assess safety.

We expect to see interim data in the first half of 2023.

Next in June we initiated preserved III.

Rajesh K. Malik: This is important as drugs with fast-track designation are eligible for more frequent engagements with the FDA to discuss a clinical development plan, potential approval pathways, priority review, and rolling NDA submission, allowing us to submit completed sections of an NDA to FDA on a rolling basis.

A phase III randomized open label study of Casella administered with first line platinum based chemotherapy and immune checkpoint inhibitor or value map as maintenance therapy, and approximately 90 patients with untreated locally advanced or metastatic <unk> or bladder carcinoma.

Rajesh K. Malik: We look forward to working closely with the FDA as we advance Costella through this ongoing pivotal program. With that, I'll turn the call over to Jen for a review of the financial results for the second quarter of 2021.

Patients are being randomly assigned 1 to 1 to 1 of 2 treatment arms in 1 arm. They will receive gemcitabine platinum chemotherapy, followed by a value map maintenance therapy.

And the other arm they.

Jen Moses: Thanks, Raj. And good afternoon, everyone. As Will mentioned, full financial results for the second quarter of 2021 are available in our press release and 10Q. Today, I will focus on a few key points from our disclosure.

We will receive casella prior to chemotherapy, followed by <unk>, plus a value added maintenance therapy the price.

Memory endpoint is to evaluate progression free survival during the overall study.

Key secondary endpoints evaluate other measures of antitumor efficacy we.

We will also evaluate the multi lineage modular protective effects of casella on chemotherapy induced model suppression and safety.

Jen Moses: Our total revenue for the second quarter of 2021 was $6.6 million.

We expect to see data in the second half of 2022.

Jen Moses: comprised of net product revenue of $2.5 million and license revenue of $4.1 million. For net product revenue, we realized a growth-to-net percentage in the mid-teens and expect to realize a growth-to-net percentage in the mid-to-high teens going forward. The main driver of variability in our growth-to-net adjustment is our percentage of sales to PHS organizations.

Finally, as we develop casella in the clinic.

Must continually ensure that we conduct trials that we believe will maximize the value of cassava.

I am happy to announce an upcoming phase III trial that we believe will help to do exactly that.

The trial is designed to evaluate the immune based anti tumor mechanism of action of Casella.

By assessing changes in the tumor microenvironment after administration of Kosovo.

And that clinical study in patients with early stage triple negative breast cancer will be looking at changes in the ratio of CD 8 T cells to T regulatory cells in the tumor microenvironment, along with a variety of other assessments of immune function following treatment with casella to further define.

Jen Moses: Our license revenue was primarily related to a $3 million development milestone payment from our license agreement with SymSeer, specifically related to the initiation of their bridging study of trilacycline in first-line and second- and third-line extensive-stage small-cell lung cancer. We benefit from this sincere partnership in a variety of ways. Of course, this includes financial benefits such as current and future milestones and royalties, but we have also discussed their ability to participate in our clinical trials. Sincere is participating in both our CRC and TNBC studies, which we believe will help not only control cash burn on these studies but also provide additional

And what we believe is a broadly applicable mechanism of action.

We expect to announce initiation of this trial later this year and we will provide more detail on the trial design at that time.

Before I conclude I'll briefly comment on our recent fast track designation for Casella in combination with chemotherapy in triple negative breast cancer.

This is important as drugs with fast track designation are eligible for more frequent engagements with the FDA to discuss the clinical development plan potential approval pathways and priority review and rolling NDA submission, allowing us to submit completed sections of an NDA to FDA on a rolling basis.

Jen Moses: but also provide additional sites to help us continue to enroll this trial at an appropriate time.

Jen Moses: Cost of Goods Sold for the three months ended...

Jen Moses: June 30, 2021 with $0.8 million. As a reminder, the majority of manufacturing costs

Jen Moses: The majority of the manufacturing costs related to Coacella sales were incurred prior to FDA approval and, therefore, were recorded as R&D expense in prior periods. These previously expensed costs will continue to impact the presentation of cost of goods sold in future periods until the initial pre-launch inventory is depleted, and additional inventory is manufactured and sold. G1's research and development expenses for the second quarter of 2021 were $18.8 million, compared to $18.5 million for the second quarter of 2020.

We look forward to working closely with the FDA as we advance <unk> through this ongoing pivotal program.

With that I'll turn the call over to Chen for our.

Review of the financial results for the second quarter of 2021 Jan.

Thanks, Raj and good afternoon, everyone as will mentioned for financial results for the second quarter of 2021 are available in our press release and 10-Q today I will focus on a few key points from our disclosure.

Our total revenue for the second quarter 2021 was $6.6 million comprised of net product revenue of $2.5 million and license revenue of $4.1 million.

For net product revenue, we realized growth to net percentage in the mid teens and expect to realize the growth to net percentage in the mid to high teens going forward.

The main driver area variability in our growth to net adjustment is our percentage of sales to Phs organization.

Jen Moses: The increase in R&D expenses was primarily due to an increase in clinical trial spend, which was offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredients and drug products to support clinical trials, as well as a decrease in external costs related to discovery and preclinical development. Selling general and administrative expenses for the second quarter of 2021 were $25.2 million compared to $14.4 million for the second quarter of 2020.

Our license revenue was primarily related to a $3 million development milestone payments from our license agreement with sincere specifically related to the initiation other bridging study of <unk> and <unk> in second and third line extensive stage small cell lung cancer.

We benefit from the <unk> partnership in a variety of ways.

This includes financial benefits, such as current and future milestones and royalties.

We have also discussed their ability to participate in our clinical trial.

Sincere and participating in both our CRC and CNBC studies, which we will believe will help not only control cash burn on these studies, but also provide additional sites to help us continue to enroll this trial at an appropriate pace.

Jen Moses: The increase in SG&A expenses was largely due to an increase in commercialization activities.

Jen Moses: an increase in compensation due to increases in headcount, an increased spend on information technology, professional services, and other administrative costs. We ended the second quarter with cash and cash equivalents of $244 million, and we expect our current financial position...

Cost of goods sold for the 3 months ended June $32021.8 million.

As a reminder, the majority of the manufacturing costs related to concession sales were incurred prior to FDA approval and therefore were recorded as R&D expense in prior periods. These previously expense cost we will continue to impact the presentation of cost of goods sold in future periods until initial prelaunch inventory is depleted.

Jen Moses: and we expect our current financial position to be sufficient to fund operations into 2023. With that, I'll turn the call back over to Jack for some closing comments.

And additional inventory is manufactured to consult.

<unk> research and development expenses for the second quarter of 2021 were $18.8 million compared to $18.5 million for the second quarter of 2020.

Increase in R&D expenses was primarily due to an increase in clinical trials.

Which is offset by a decrease in costs associated with the manufacturing of active pharmaceutical ingredient and drug product to support clinical trials as well as a decrease in external costs related to discovery and preclinical development.

Our selling general and administrative expense for the second quarter of 2021 for $25.2 million compared to $14.4 million for the second quarter of 2020.

John E. Bailey: We are well aware of the importance of the work we are doing at G1 for patients with lung cancer and that there is a great need for this first and only proactive multilineage myeloprotection treatment. Now, before we move to Q&A, let me just recap what you've heard. The combined commercial team is heavily focused on executing the plan in the second quarter and took early steps forward to getting Coacella widely tried and adopted over the long term. We have no issues with reimbursement.

The increase in SG&A expense was largely due to an increase in commercialization activity an increase in compensation due to increases in head count and increased spend on information technology professional services and other administrative costs.

Thank you Jen Roger will now before we close the call I wanted as always for people living with cancer for their inspiration because we know we're only a couple of days past the world lung cancer day, I'd like to specifically acknowledge those families who have experienced the impact of lung cancer past and presence in the important work that for.

Graphic oncologists oncology nurses and their staffs do to care for people living with it.

We are well aware of the importance of the work we're doing at Q1 for patients with lung cancer and that there is a great need for this first and only proactive multi lineage Milo protection drunk.

Before we move to Q&A, let me just recap what you've heard today.

The combined commercial team is heavily focused on executing the plan in the second quarter and took early steps forward getting co sell a wildly driving adopted over the long term we have no issues with reimbursement we continue to hold the majority of our sales calls virtually we do expect that to change over time, however, as the U S continue.

<unk> opened up but we will monitor the impact of Covid bearings, and instances, where our target organizations day virtual we will continue to adapt to ensure that we are reaching them as effectively as possible.

We initiated 3 new trials in the second quarter, a phase III Registrational trial in metastatic triple negative breast cancer and 2 phase II trials in patients with non small cell lung cancer.

For the bladder cancer.

We also expect to initiate a new phase III trial later this year to further define the anti tumor mechanism of action of <unk>.

John E. Bailey: And finally, our Cash Runway Guidance is unchanged from our last Setup Guidance, taking us into 2023. Thank you for your time this afternoon. We will speak again in this format on the November call, though I'm sure we'll see many of you before then during the late summer and fall slate of virtual healthcare conferences and non-deal roadshows. Hopefully, we can see many of you in person in due time as well. 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?

As a result, we expect to have numerous data readouts starting in the second half of next year.

We've recently received fast track designation for Casella in Triple negative breast future, which is a regulatory pathway used to get important new drugs to the patient earlier by providing regulatory support and other benefits and finally, our cash runway guidance is unchanged from our last set of guidance taking us into 2020.

Thank you for your time. This afternoon, we will speak again in this format on the November call for I'm sure. We'll see many of you before then during the late summer and fall slate of virtual health care conferences and non deal Roadshows hopefully we can see many of you in person in due time as well 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.

Thank you, Sir and as a reminder to ask a question. Please press the star and the number 1 key on your tax stone telephone. Thank for your question has been answered or you wish to remove yourself from the queue. Please go ahead.

Chad Messer: Good evening and congratulations on a solid quarter, early on a lot of milestones being met.

Chad Messer: I'm wondering if you could educate us a little bit further on the importance of...

Okay.

Your first question comes from the line of Chad Messer from Needham <unk> Company. Your line is open.

Chad Messer: The NTAP decision that you reported this morning, there was an actual amount that sort of a maximum reimbursement amount that was given. And I'll end on that note, and I apologize if this is my own naivety, but maybe put some perspective on that and maybe talk about its importance, as well as if there's any more you can say about the C and J codes, which were also recently granted. Getting reimbursed is, uh, it's a

Yes.

Okay.

Good evening.

And congrats on the.

Solid quarter.

Got it.

A lot of milestones being met.

I'm wondering if you could educate us a little bit for there on the importance of the.

And Catherine decision that you reported this morning.

Chad Messer: It's a pretty major factor to encourage uptake.

John E. Bailey: Yeah, thanks Chad. I appreciate the questions. You know, when you look at both the NTAP, the C-code, and the J-code, I mean, it all speaks to, frankly, what we would view as a very positive reimbursement environment. All of those, of course, are via CMS. We also have the commercial market, which, as we mentioned, every payer is allowing claims for Coacella to flow through according to label, and several have written formal policies. So, I think it all speaks to your point. What is normally one of the biggest concerns early in a product launch is coverage and reimbursement. We feel very, very good.

If there was a.

And actual amounts that sort of a maximum reimbursement amount that was.

Given.

This is my own EBIT, but maybe you can put some perspective on that and maybe talk about that importance as well.

If there's any more you can say about that.

C J.

J codes withdrawal.

Recently.

Granted.

Obviously at this point and launch.

Getting reimburse us.

Yes.

Pretty major factor to uptake.

Yes, Thanks, Chad I appreciate the questions.

When you look at both the untapped a C code and the J code I mean, it all speaks to frankly, what we would view as a very positive reimbursement environment. All of those of course are via CMS.

John E. Bailey: My personal experience says this is as good as I've seen it in probably a decade or a decade and a half for a new product, whether it's commercial or Medicare patients. Now, in terms of the NTAP itself, it's more specific for those minority of patients that will be started in the inpatient setting. So, that is a very small percentage of Coacella patients based upon our market research, but when you couple that with the C-code and then the J-code, basically, you've got the entire waterfront covered. That's what I would share on the intent. It's helpful, but when you look at it in the totality, it's really just an extremely positive coverage and reimbursement environment.

We also have the commercial market, which as we mentioned.

Every payer is allowing claims for cross sell up to flow through according to label and several have written formal policy. So I think it all speaks to to your point what is normally 1 of the biggest concerns early on a product launch is coverage and reimbursement we feel very very good my personal experience.

So this is as good as I've seen it in probably a decade or executive in the half for new product, whether it's commercial or Medicare patients now in terms of the untapped itself. It's more specific for those minority of patients that will be started in the inpatient setting. So that is a very small percentage.

Of course, our patients based upon our market research, but when you couple that with the C code and the J code.

Basically we've got the entire waterfront covered so.

That's what I would share on the untapped.

It's helpful.

But it's really when you look at it.

In the totality, it's really just an extremely positive coverage and reimbursement environment.

Chad Messer: All right, great, thanks. Very helpful, and congratulations again. Thank you.

Alright, great. Thanks, very helpful and congrats again.

Thank you Jeff.

Operator: And your next question comes from the line of Joseph Thome from Cohen and Company. Your line is open.

And your next question comes from the line of Joseph <unk> from Cowen and company. Your line is open.

Joseph John: Good evening, and thank you for taking our questions.

Good evening and thank you for taking my questions.

Joseph John: Maybe the first one; it was indicated that, you know,

Maybe the first 1 it was indicated that some some areas seem to be outperforming and maybe others for our underperforming.

Joseph John: Some areas seem to be outperforming, and maybe others are underperforming.

Joseph John: Um, are there any specific reasons why that might be happening? Is it based on geography?

Are there any specific reasons why that might be happening is it based on geography or maybe some price.

Using sort of supportive care agents or somewhere clinical trials like this.

Operator: https://www.kenhub.com

For information on how it would be helpful.

Joseph John: I think that's a reasonable step forward. Thanks.

And then maybe on the <unk>, obviously, we're expanding the development of Capella here was that upcoming study.

We then be looking for kind of per Castello with other maybe accrued eclipsed base like an ECB.

<unk> was approved last year.

<unk>.

Reasonable.

Thanks.

Sure I'll handle the first 1.

And then I'll flip it over to Raj in the second 1.

This is really it's more on the execution side.

Joe.

Certainly there is no geographic boundaries when it comes to small cell lung cancer. So it days and this is really is execution were aligned with our partner on that.

We know what the issues are.

Some of it requires training some of its more attention.

John E. Bailey: But the bottom line is it is solvable, and we are working forward to making sure we solve that across the country. In terms of the TMBC study and potential thoughts on that, let me turn that to Raj.

For the bottom line is solvable and we are working for making sure we saw that across the country in terms of the PBC study potential Boston that let me turn that Suraj, Yes, Hey, Joe Yes for that MLA CNBC study, we are very excited about further define the mechanism.

John E. Bailey: Yeah, hey Joe. Yeah, so that MOA...

Rajesh K. Malik: This TMBC study we are very excited about to further define the mechanism. There's a lot of data on the effect of Cocella on Tregs in particular and the CD8 to Treg ratio, so that will be our focus. And we'll talk more about that as we near the initiation of the study. Regarding ADC, yes, we're definitely interested in...

There's a lot of data on the effect of Casella on T. Regs in particular on CD 8 T. Reg ratio, so that will be our focus and we'll talk more about that.

As we near initiation of the study.

Regarding ADC, yes, we're definitely interested in exploring that study as well.

Rajesh K. Malik: exploring that study as well, since this is a class of drugs that's clearly, you know, becoming entrenched in a number of spaces, including TMT. Great, thank you, and congratulations.

As for the class of drugs.

Clearly.

Becoming entrenched in the number of number of spaces, including CNBC.

Great. Thank you and congratulations.

Thank you.

Operator: And your next question comes from the line of Tom Schrader from BTIG. Your line is open.

No.

And your next question comes from the line of Tom Shrader from BPI G. Your line.

It is open.

Tom Schrader: Good afternoon. Congratulations.

Hey, good afternoon, congratulations not an easy time to launch it.

Tom Schrader: Not an easy time to launch a drug. I had a couple of questions about the clinical trials you announced. What is your sense about how many trials you're going to have to run? If you show myelopreservation in second line, third line, and non-small-cell lung

Hello.

Couple of questions on the clinical trials you announce.

What is your sense about how many trials you're going to have to run on the few show Milo preservation in second line third line non small cell lung cancer do you think you would get an approval for first line as well or is it.

Tom Schrader: Do you think you would get approval for the first line as well?

Tom Schrader: line as well, or is there just no way to know? Just your sense. How many trials do you have to do?

No way to know just your sense.

How many trials you have to do.

John E. Bailey: Yeah, it's a fair question, Tom. We appreciate it, and I think a lot of folks have tried to figure this one out.

Yes.

It's a fair question, Tom we appreciate it and I think a lot of folks have tried to figure. This 1 out I don't think we have a great answer for you beyond we're going to we really have a tumor agnostic vision for cross sell up and so we're going to continue to execute on these studies to try and buildup at repository of.

John E. Bailey: I don't think we have a great answer for you beyond that we really have a tumor-agnostic vision for Cocella, and so we're going to continue to execute on these studies to try and build up that repository of proof across an array of different regimens and tumor types. So, you know, whether or not at some point regulators choose to give it a broader label is tough to predict. What I would say is, you know, a lot of the payers in the compendia listings will take a different perspective and begin to reimburse, so I think we have to separate the two, sort of a formal regulatory label change after so many studies versus getting reimbursement with a broader label.

A proof across an array of different regimens in tumor type so.

Whether or not at some point regulators.

Choose to give it a broader label, it's tough to predict what I would say is.

A lot of other payers in the compendium listings up well take a different perspective and begin to reverse. So I think we have to separate the 2 sort of a path formal regulatory label change. After so many studies versus getting reimbursement for the broader label, so, but we're going to continue to execute on these and again, we're encouraged with things like the past.

John E. Bailey: So, but we're going to continue to execute on these, and again, we're encouraged by things like the Fast-Track designation where we can continue to engage with the regulatory bodies that will make sure we can get Cocella brought to market for these broader indications. Great, and a second question on the urothelial trial. So you're maintaining Cocella during the...

Track designation, where we can continue to engage with the regulatory bodies.

I will make sure we can get to sell up brought to market for these broader decisions.

Yes.

Second question on the <unk> trial, so you're maintaining co seller during the available value lab value Mab maintenance only.

Tom Schrader: ValueLab and ValueMap maintenance only.

Tom Schrader: What's going on there? Is there enough Cocella to have efficacy? Are CDK4-6s active here? Just a thought on extending Cocella use.

What's going on there is there enough casella to have efficacy as our CDK for <unk> active here are just a thought on extending that could certainly use.

Rajesh K. Malik: Hey Tom, this is Raj.

Rajesh K. Malik: Thank you, Raj. So, sorry if that was not clear in my remarks.

Yes, Hey, Tom This is Raj.

So sorry, if I was not clear in my remarks.

Rajesh K. Malik: The design is patients get up to six cycles of general flatness, and then if the disease has not progressed, they will receive Valumab as maintenance. So that is the control arm. We're going to get Costella with gemcitabine platinum as well as Valumab maintenance throughout the duration.

The design is patients get up to 6 cycle that G object flatten out and then if the disease has not progressed they will receive a value mab is maintenance so that as the control arm, we are going to get casella with gemcitabine platinum as well as a value map.

So it's throughout the duration of treatment.

Rajesh K. Malik: There's actually, you know, we have data pre-clinical and all of our mechanism of action data.

In terms of Casella.

Theres actually.

We have data pre clinically and all of our mechanism of action data suggest that.

Rajesh K. Malik: The mechanism of action data suggests that there's a good rationale for combining it with a checkpoint inhibitor, both alone as well as in combination with chemo and checkpoints. So that's the rationale.

There's a good rationale for combining it with with a checkpoint inhibitor both alone as well as in combination with chemo and checkpoints. So that's the rationale for the design.

Operator: And your next question comes from the line of David Nierengarten from Redbush Securities. Your line is open.

Alright, great. Thanks.

And your next question comes from the line of David Reichman from Wedbush Securities. Your line is open.

David Matthew Nierengarten: Thanks for taking the questions. Maybe, if I could, a little bit more detail on the in-tab payment, you know, specifically, where does that place you relative to the physician's reimbursement relative to other new LASTAs or other white cell support agents? And then a second question on the bladder cancer study. Are there, I mean, obviously, you'll be watching for myelosuppression in there? Is there a plan or scenario where if you don't necessarily see, you know, a stat sick benefit on progression-free survival, is there a mechanism to maybe expand the study or to, you know, look at a myelopreservation endpoint to, you know, accelerate the process of getting a broader approval and multiple tumor types for at least myelopreservation? Thanks. Yeah, I'll take the first one.

Hey, Thanks for taking the questions maybe if.

If I could a little bit more detail on the tab.

<unk> payment.

Specifically.

Where does that place you relative.

Are you on the physicians reimbursement relative to other.

Yes.

Neulasta is or other whitesell support agents.

And then a second question on the bladder cancer study are there.

I mean, obviously youll be watching for Milo suppression in there is there a plan or a scenario, where if you don't necessarily see a stat sig benefit on progression free survival is there a mechanism to maybe expand the study or 2.

Look at myeloid preservation endpoint to Tom's point.

Yes.

John E. Bailey: Yeah, I'll take the first one on the NTAP, and then I'll have Rajesh speak a little bit more on the bladder. Yeah, on the NTAP, I mean, first of all, if you look at the economics, especially for the inpatient setting, where the NTAP is more applicable, whether you look at it from a net cost recovery perspective or from an administration fee, the economics are very favorable for Cocella. The NTAP really avoids, and the whole intent of it when it started years ago, was to not penalize providers in that DRG setting where there's one set payment, and new innovation comes in, and the healthcare system may avoid using it, even if it's got the potential to improve patient outcomes, et cetera.

Accelerate the process of getting a broader approval in multiple tumor types for at least Milo preservation. Thanks.

Yes, I'll take the first 1 on the impact and then I'll, let Roger speak a little bit more on the bladder yes.

Yes, I mean first of all if you look at the economics, especially for the inpatient setting where again the impact is more applicable whether you look from a net cost recovery for from an administration fee. The economics are very favorable for casella.

The untapped really avoids and the whole intent of it when it started years ago was to not penalize, our net DRG setting orders 1 set payment and new innovation comes in and the health care system may avoid using it EBIT if its got the potential to improve patient outcomes et cetera. So from our standpoint I would say.

John E. Bailey: So from our standpoint, I would say it just continues to provide Cocella with favorable economics in that inpatient setting. But again, I would just go back to the broader issue of coverage and reimbursement, which is really the key takeaway. We've got, frankly, a really optimal scenario here, whether it's for those Medicare patients or for those commercial patients.

It just continues to have.

Provide for solar with favorable economics, you'd net inpatient setting, but again I would just go back to the broader issuance coverage and reimbursement is really the key takeaway. We've got frankly, a really optimal scenario, whether it's for those Medicare patients or for those commercial pension so but in turn.

Rajesh K. Malik: Yeah, hey, David. Yeah, so there are two comments I'd make. The first is that this is an open-label study. So obviously, we would be looking at the data, and if there is a strong model signal, I think that is certainly a possibility.

For bladder will need to have Raj speak to that yeah, Hey, David Yeah. So this is 1 to 2 comments I'd make the first debt. This is an open label study.

So obviously with it.

We'll be looking at the data and if there is a strong model signal I think that is certainly a possibility.

Rajesh K. Malik: I think that is certainly a possibility. The second is that, in our experience to date, when there is a myelosignal, it's apparent in relatively small numbers of patients.

Second is that.

In our experience to date when there is a model of signal it's apparent in relatively small numbers of patients. This is 90 patients 45 per arm. So the size of the study could be sufficient to actually pick that up as well.

Yes.

David Matthew Nierengarten: Yeah, I mean, part of that was, you know, what is the kind of background rate for myelosuppression in bladder patients? So I assume it's sufficient to see a delta then, as you mentioned, in a short order or with fewer patients. Yeah, so this is really both; it includes both gem sites.

Yes.

Yes that would be par.

That was what is the kind of background rate on myeloid suppression and bladder patient. So I assume it's sufficient to see a delta then as you mentioned it in a short order or with fewer patients.

Yes. So this is really both includes both gemcitabine and cisplatin and cargo so assist as the preferred but insists on an eligible we'd get cargo and day or both.

Rajesh K. Malik: Yeah, so this is really both; it includes both gemcitabine, cisplatin, and carbo, so cis is preferred, but in cis is ineligible.

Obviously minus a process. So yes, I think it's a reasonable number of patients too.

Rajesh K. Malik: Myelosuppressives. So yeah, I think it's a reasonable number of patients to get a read on that.

To get a get a read on that.

Got it thank you.

Thank you David.

Once again, if you would like to ask a question Press Star then the number 1 key touchstone telephone. Thank for your question has been answered or you wish to remove yourself from the queue. Please press the pound key.

And your next question comes from the line of Tony Butler from Roth Capital. Your line is open.

Yes, thanks very much just just.

Tony Butler: Yes, thanks very much. Just really two questions, and they're on the Clinical Trials which are enrolling and ongoing. I noticed, Raj, on clinicaltrials.org, that Preserve 3 and bladder cancer currently have only one side enrolling patients, and I wondered if you would speak to that. And then also, with respect to...

Really 2 questions in there on the.

Clinical trials, which are enrolling and ongoing.

I noticed rising clinical trial started work that preserve 3 in bladder cancer.

Currently has only 1 site enrolling patients and I wondered if you could speak to that.

And then also with respect to.

Preserved for.

Tony Butler: Preserve 4 in NSCLC. There are four sites. It seems that there's a tremendous amount of activity going on, certainly in Preserve 1 and Preserve 2, so I just wanted, and I realize they're new, and I

And then our CLC there or for sites. It seems that theres, a tremendous amount of activity going on certainly in preserve 1 preserve too so I just wanted to.

And I realized for new and I know having for trials ongoing can be cumbersome for a small company.

Rajesh K. Malik: Yeah, hey, Tony. So yeah, no, we're both in both studies, so one was initiated in May.

But I appreciate your thoughts on on the site.

Thank you.

Yes, Hey, Tony So yes, we are.

Both studies for 1 initiated in May the other 1 in June so we're very much in the site activation.

Rajesh K. Malik: The other one in June, so we're very much in the site activation part of the study, and the other, the other point actually is

Part of the study and the other the other point actually is.

There are more sites than are currently visible on Central's top golf. It always takes a couple of days for them to be updated and that's a continuous process.

Rajesh K. Malik: And the other point, actually, is that there are more sites than are currently visible on clintrials.gov.

So, yes, but but but patients are being enrolled we've enrolled patients other non small cell lung cancer study and.

Rajesh K. Malik: We've enrolled patients on the NOSMOS Lung Cancer Study, and we expect the same to happen in bladder cancer soon.

And we expect the same to happen in bladder soon.

Rajesh K. Malik: We expect the same to happen at Bladder soon.

I appreciate your comments sure. Thank you Tony.

Sure.

Operator: I'm showing no further questions at this time. I would now like to turn the conference back to Mr. Jack Bailey. Please go ahead, sir.

I'm showing no further question at this time I would now like to turn the conference back to Mr. Jeff Bailey. Please go ahead Sir.

Thank you operator, we.

John E. Bailey: We are actively bringing Cocella to patients with extensive stage small cell lung cancer and conducting these intelligently designed clinical trials to maximize the future value and applicability of this unique drug in a variety of cancers. As always, I look forward to keeping you updated as we move forward. Thank you for joining us today. Have a good afternoon.

We are actively bringing <unk> to patients with extensive stage small cell lung cancer and conducting these intelligently designed clinical trials to maximize the future value of the flexibility of this unique drug in a variety of cancers.

As always I look forward to keeping you updated as we move forward. Thank you for joining us today and good afternoon.

Operator: And this concludes today's conference call. Thank you all for your participation and have a wonderful day. You may all disconnect.

And this concludes today's conference call. Thank you all for your participation and have a wonderful day you may all disconnect.

Q2 2021 G1 Therapeutics Inc Earnings Call

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